28 Pharmaceutical jobs in Ireland
Clinical Research Associate
Dublin, Leinster
Grifols Shared Services North America, Inc
Posted today
Job Viewed
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
**POSITION SUMMARY:**
Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provides support in the oversight and management of vendors. Conducts review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol.
**KEY RESPONSIBILITIES:**
+ Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study.
+ Has a good knowledge of the therapeutic area and product.
+ Obtains a complete understanding of all trial-related documents and operational procedures with moderate direct supervision
**Audits/Inspections/Quality Assurance (QA):**
+ Supports with effective and timely audit/inspection responses.
**Clinical Trial Design/Performance:**
+ Gains exposure/participates in case report form (CRF) development, interactive "X" recognition system (IXRS) set-up, central laboratory (lab) set-up, and other vendor selection processes and is capable of training others.
+ Oversees completion of Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), to determine protocol and regulatory compliance.
+ Contributes to the resolution of escalated issues from study centers, regulatory authorities and institutional review board (IRBs)/independent ethics committees (IECs) with the support of the supervisor, if needed.
+ Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report.
+ Oversees study centers to ensure timely execution of the clinical studies, generating quality data ensuring the well-being of the study subjects and the trial integrity with moderate supervision.
+ With the support from the supervisor, may support in the creation, review and tracking of study documents.
+ May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed.
**Clinical Trial Materials (CTM):**
+ Provides support on the regulatory document review and approval for investigational product (IP) release.
+ Provides support in clinical product technical complaints and product recall as necessary.
+ Provides support and information to the CTM staff regarding IP management, as needed.
**In-house Monitoring:**
+ May assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ May facilitate investigator site payments, as applicable.
**Management/Training Team** :
+ Ability to facilitate meetings (e.g. Investigator Meetings, Kick-off meetings).
+ May provide support for the monitor training and contribute to resolve the issues they identified.
+ Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).
**Monitoring:**
+ Reviews and tracks comments of monitoring reports generated by the vendor (i.e. CRO) as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities.
+ With the support of the supervisor, if needed, verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Tracks study specific tasks and progress of the trial.
+ Gets more insight, maintains and updates clinical trial management system (CTMS) information pertaining to the study.
+ Is involved in the oversight of vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible.
+ May collaborates with data management to resolve queries.
**Vendor Management:**
+ Assists in the management of vendor performance during conduct of the study with moderate direct supervision.
+ Assists in evaluation of vendor performance during conduct of the study.
+ Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation, with moderate supervision.
+ Facilitates the scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed.Additional On-site Monitoring Responsibilities:
**In-house Monitoring:**
+ Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Conducts completion of PSVs, SIVs, IMVs, and COVs, to determine protocol and regulatory compliance.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
**Monitoring:**
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.Safety:
+ Understands and supports implements processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.
**PERSON SPECIFICATION**
+ Typically requires 2 years of experience in clinical research, including a minimum of 1-year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ Associate's degree in a life science field required.
+ Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring).
+ 4 years clinical research experience with 2 years experience as a CRA
+ Bachelor's degree or higher degree in a life science field preferred.
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
+ Private Medical Insurance for the employee (Irish Life)
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you
#LI-FD1
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:**
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
**POSITION SUMMARY:**
Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provides support in the oversight and management of vendors. Conducts review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol.
**KEY RESPONSIBILITIES:**
+ Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study.
+ Has a good knowledge of the therapeutic area and product.
+ Obtains a complete understanding of all trial-related documents and operational procedures with moderate direct supervision
**Audits/Inspections/Quality Assurance (QA):**
+ Supports with effective and timely audit/inspection responses.
**Clinical Trial Design/Performance:**
+ Gains exposure/participates in case report form (CRF) development, interactive "X" recognition system (IXRS) set-up, central laboratory (lab) set-up, and other vendor selection processes and is capable of training others.
+ Oversees completion of Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), to determine protocol and regulatory compliance.
+ Contributes to the resolution of escalated issues from study centers, regulatory authorities and institutional review board (IRBs)/independent ethics committees (IECs) with the support of the supervisor, if needed.
+ Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report.
+ Oversees study centers to ensure timely execution of the clinical studies, generating quality data ensuring the well-being of the study subjects and the trial integrity with moderate supervision.
+ With the support from the supervisor, may support in the creation, review and tracking of study documents.
+ May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed.
**Clinical Trial Materials (CTM):**
+ Provides support on the regulatory document review and approval for investigational product (IP) release.
+ Provides support in clinical product technical complaints and product recall as necessary.
+ Provides support and information to the CTM staff regarding IP management, as needed.
**In-house Monitoring:**
+ May assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ May facilitate investigator site payments, as applicable.
**Management/Training Team** :
+ Ability to facilitate meetings (e.g. Investigator Meetings, Kick-off meetings).
+ May provide support for the monitor training and contribute to resolve the issues they identified.
+ Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).
**Monitoring:**
+ Reviews and tracks comments of monitoring reports generated by the vendor (i.e. CRO) as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities.
+ With the support of the supervisor, if needed, verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Tracks study specific tasks and progress of the trial.
+ Gets more insight, maintains and updates clinical trial management system (CTMS) information pertaining to the study.
+ Is involved in the oversight of vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible.
+ May collaborates with data management to resolve queries.
**Vendor Management:**
+ Assists in the management of vendor performance during conduct of the study with moderate direct supervision.
+ Assists in evaluation of vendor performance during conduct of the study.
+ Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation, with moderate supervision.
+ Facilitates the scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed.Additional On-site Monitoring Responsibilities:
**In-house Monitoring:**
+ Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Conducts completion of PSVs, SIVs, IMVs, and COVs, to determine protocol and regulatory compliance.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
**Monitoring:**
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.Safety:
+ Understands and supports implements processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.
**PERSON SPECIFICATION**
+ Typically requires 2 years of experience in clinical research, including a minimum of 1-year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ Associate's degree in a life science field required.
+ Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring).
+ 4 years clinical research experience with 2 years experience as a CRA
+ Bachelor's degree or higher degree in a life science field preferred.
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
+ Private Medical Insurance for the employee (Irish Life)
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you
#LI-FD1
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:**
This advertiser has chosen not to accept applicants from your region.
0
QA Regulatory Compliance Specialist
PCI Pharma Services
Posted 2 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
#LI-JP1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
#LI-JP1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
1
Pharma Account Manager
Dublin, Leinster
UnitedHealth Group
Posted 5 days ago
Job Viewed
Job Description
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.
**About the Role:**
As a Fortune 5 business, we're one of the world's leading healthcare companies. There are no limits here on the resources you'll have or the challenges you'll encounter.
We have been supporting global healthcare systems from Ireland and the UK for more than 20 years, building a dynamic and diverse team of more than 2,100 talented individuals. With a continued record of growth and stability, we're on the constant lookout for fresh talent to join our expanding teams.
We are looking for an experienced, curious and self-motivated individual who will be responsible for working within a Pharma Services team dedicated to providing key account management to major Pharmaceutical Manufacturers based in the US. The successful candidate will report to the Director of Pharma Services, Emisar. We are looking for people who can collaborate cross-functionally with various business and data analytics teams, demonstrate exceptional attention to detail, have a customer focused mindset, and the ability to manage multiple competing business projects at one time.
_Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny offices and telecommuting from a home-based office in a hybrid work model_
**Primary Responsibilities:**
- Perform within a team of account and service managers aimed at developing and promoting net new administrative services for Pharmaceutical Manufacturers based in the US.
- Work with key business owners to lead, inform, and direct the development of an extensive portfolio of new and innovative GPO tools and services that will be delivered to Pharmaceutical Manufacturers in 2026 and 2027. Ideation, scoping of work, and UX consulting throughout 2024, with product development, value optimization, testing, and stakeholder engagement throughout 2025 and 2026.
- Coordinate with GPO Business Development team to maximize efforts to improve operational efficiency, centralization of data, utility of dashboards and business tools, and other initiatives to improve overall competitiveness and profitability.
- Be involved in the operational activities related to Pharma Services.
- Provide executive summaries to senior individual(s) including the organization of presentations and the analysis and interpretation of information/data.
- Actively seeks to improve current and future processes and coordinate organizational procedures for optimized efficiency.
- Work towards objectives and deliverables, and work across cross-functional teams to deliver against initiative.
- Manage regular reports and updates for the leadership team, and executive team reflecting business performance and priorities.
- Create and articulate business case for highest impact product opportunities.
**Required Qualifications:**
- Undergraduate degree or equivalent.
- Proven ability to work collaboratively across a matrix environment to deliver business goals.
- Experience in working with and analyzing diverse datasets to develop business insight and strategy.
- Proven ability to work on projects with accountability of work to senior management level stakeholders.
- Understanding of competitive landscape and familiarity with pharmaceuticals or healthcare industry.
- Excellent verbal and written communication skills. Ability to speak clearly and concisely, conveying complex or technical information in a manner that others can understand, as well as ability to understand and interpret complex information.
**Preferred Qualifications:**
- Experience in managed health care or pharmacy benefit management
- Advanced degree (e.g. MBA)
**Please note you must currently be eligible to work and remain indefinitely without any restrictions in the country to which you are making an application. Proof will be required to support your application.**
All telecommuters will be required to adhere to the UnitedHealth Group's Telecommuter Policy.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalised groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.
Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © 2023 Optum Services (Ireland) Limited. All rights reserved.
**About the Role:**
As a Fortune 5 business, we're one of the world's leading healthcare companies. There are no limits here on the resources you'll have or the challenges you'll encounter.
We have been supporting global healthcare systems from Ireland and the UK for more than 20 years, building a dynamic and diverse team of more than 2,100 talented individuals. With a continued record of growth and stability, we're on the constant lookout for fresh talent to join our expanding teams.
We are looking for an experienced, curious and self-motivated individual who will be responsible for working within a Pharma Services team dedicated to providing key account management to major Pharmaceutical Manufacturers based in the US. The successful candidate will report to the Director of Pharma Services, Emisar. We are looking for people who can collaborate cross-functionally with various business and data analytics teams, demonstrate exceptional attention to detail, have a customer focused mindset, and the ability to manage multiple competing business projects at one time.
_Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny offices and telecommuting from a home-based office in a hybrid work model_
**Primary Responsibilities:**
- Perform within a team of account and service managers aimed at developing and promoting net new administrative services for Pharmaceutical Manufacturers based in the US.
- Work with key business owners to lead, inform, and direct the development of an extensive portfolio of new and innovative GPO tools and services that will be delivered to Pharmaceutical Manufacturers in 2026 and 2027. Ideation, scoping of work, and UX consulting throughout 2024, with product development, value optimization, testing, and stakeholder engagement throughout 2025 and 2026.
- Coordinate with GPO Business Development team to maximize efforts to improve operational efficiency, centralization of data, utility of dashboards and business tools, and other initiatives to improve overall competitiveness and profitability.
- Be involved in the operational activities related to Pharma Services.
- Provide executive summaries to senior individual(s) including the organization of presentations and the analysis and interpretation of information/data.
- Actively seeks to improve current and future processes and coordinate organizational procedures for optimized efficiency.
- Work towards objectives and deliverables, and work across cross-functional teams to deliver against initiative.
- Manage regular reports and updates for the leadership team, and executive team reflecting business performance and priorities.
- Create and articulate business case for highest impact product opportunities.
**Required Qualifications:**
- Undergraduate degree or equivalent.
- Proven ability to work collaboratively across a matrix environment to deliver business goals.
- Experience in working with and analyzing diverse datasets to develop business insight and strategy.
- Proven ability to work on projects with accountability of work to senior management level stakeholders.
- Understanding of competitive landscape and familiarity with pharmaceuticals or healthcare industry.
- Excellent verbal and written communication skills. Ability to speak clearly and concisely, conveying complex or technical information in a manner that others can understand, as well as ability to understand and interpret complex information.
**Preferred Qualifications:**
- Experience in managed health care or pharmacy benefit management
- Advanced degree (e.g. MBA)
**Please note you must currently be eligible to work and remain indefinitely without any restrictions in the country to which you are making an application. Proof will be required to support your application.**
All telecommuters will be required to adhere to the UnitedHealth Group's Telecommuter Policy.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalised groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.
Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © 2023 Optum Services (Ireland) Limited. All rights reserved.
This advertiser has chosen not to accept applicants from your region.
2
Scientist II (Pharma)
Athlone, Leinster
ThermoFisher Scientific
Posted 5 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Scientist II - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. This role will be based at our GMP Laboratories in Athlone, Ireland.
**Discover Impactful Work:**
The role of **Pharma** **Scientist** is to perform a variety of complex sample preparation and analysis procedures to quantitatively measure small molecules using a wide range of analytical instrumentation. Working mainly independently, Scientists will interpret analytical data in regard to acceptability and consistency and set up and maintain analytical instrumentation.
**A day in the Life**
+ Perform a variety of complex sample preparations
+ Analysis procedures to quantitatively measure pharmaceutical compounds in a variety of formations for stability testing and other studies for analytical testing support
+ Review and compilation of results
+ Performing work assignments accurately, timely and in a safe manner
+ Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
+ Works with multiple functional groups to meet business needs.
+ Sets up and maintains analytical instrumentation.
+ Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
+ Ensures QA findings are addressed appropriately.
+ Communicates project status to project leader.
+ Performs work assignments accurately, and in a timely and safe manner.
+ Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
**Education and Experience**
+ Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry
+ 2+ years' relevant industry experience within a GMP laboratory (with experience in the following lab testing areas HPLC, GC, MS, Dissolution testing, Karl Fischer, UV-vis, FT-IR, TOC.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Proven ability to interpret data by performing trend analysis
+ Proven technical writing skills
+ Proven problem solving skills
+ Detailed knowledge of method validation; method development would be an advantage.
+ The ability to plan, schedule and carry out work for successful project completion
+ A positive attitude and ability to work well with others
+ The ability to write protocols and reports with minimum supervision
+ Excellent attention to detail
+ Be able to communicate effectively and follow detailed written and verbal instruction
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Scientist II - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. This role will be based at our GMP Laboratories in Athlone, Ireland.
**Discover Impactful Work:**
The role of **Pharma** **Scientist** is to perform a variety of complex sample preparation and analysis procedures to quantitatively measure small molecules using a wide range of analytical instrumentation. Working mainly independently, Scientists will interpret analytical data in regard to acceptability and consistency and set up and maintain analytical instrumentation.
**A day in the Life**
+ Perform a variety of complex sample preparations
+ Analysis procedures to quantitatively measure pharmaceutical compounds in a variety of formations for stability testing and other studies for analytical testing support
+ Review and compilation of results
+ Performing work assignments accurately, timely and in a safe manner
+ Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
+ Works with multiple functional groups to meet business needs.
+ Sets up and maintains analytical instrumentation.
+ Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
+ Ensures QA findings are addressed appropriately.
+ Communicates project status to project leader.
+ Performs work assignments accurately, and in a timely and safe manner.
+ Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
**Education and Experience**
+ Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry
+ 2+ years' relevant industry experience within a GMP laboratory (with experience in the following lab testing areas HPLC, GC, MS, Dissolution testing, Karl Fischer, UV-vis, FT-IR, TOC.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Proven ability to interpret data by performing trend analysis
+ Proven technical writing skills
+ Proven problem solving skills
+ Detailed knowledge of method validation; method development would be an advantage.
+ The ability to plan, schedule and carry out work for successful project completion
+ A positive attitude and ability to work well with others
+ The ability to write protocols and reports with minimum supervision
+ Excellent attention to detail
+ Be able to communicate effectively and follow detailed written and verbal instruction
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
3
Sr Research Scientist - Pharma
Athlone, Leinster
ThermoFisher Scientific
Posted 5 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Research Scientist - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.
**Discover Impactful Work:**
The Senior Research Scientist - Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
**A day in the Life:**
+ Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
+ Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
+ Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
+ Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
+ Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
+ Reviews protocols, project status reports, final study reports and other projectrelated technical documents.
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Keys to Success:**
**Education & Experience**
+ Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
+ 10+ years' relevant industry experience within a GMP laboratory
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Effective written and oral communication skills as well as presentation skills
+ Knowledge and application of industry best practices not yet represented by global regulatory requirements
+ Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
+ Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
+ Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
+ Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
+ Ability to independently review and understand project proposals/plans
+ Proven ability in technical writing skills
+ Ability to work in a collaborative work environment with a team
+ Proven problem solving and troubleshooting abilities
+ Ability to independently optimize analytical methods
+ Time management and project management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Senior Research Scientist - Pharma**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP Lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development and this role is based in our Pharma lab.
**Discover Impactful Work:**
The Senior Research Scientist - Pharma oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
**A day in the Life:**
+ Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
+ Acts as on-site Subject Matter Expert (SME) for various instrumentation / technique / technology and validation/method transfer.
+ Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
+ Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
+ Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
+ Reviews protocols, project status reports, final study reports and other projectrelated technical documents.
+ Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
+ Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
**Keys to Success:**
**Education & Experience**
+ Educated to a bachelor's degree level in a relevant Scientific area, ie chemistry, biochemistry
+ 10+ years' relevant industry experience within a GMP laboratory
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills, Abilities**
+ Effective written and oral communication skills as well as presentation skills
+ Knowledge and application of industry best practices not yet represented by global regulatory requirements
+ Effective, proven experience with method development, validation and the associated regulatory and ICH requirements of same
+ Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
+ Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
+ Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
+ Ability to independently review and understand project proposals/plans
+ Proven ability in technical writing skills
+ Ability to work in a collaborative work environment with a team
+ Proven problem solving and troubleshooting abilities
+ Ability to independently optimize analytical methods
+ Time management and project management skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
4
Senior Project Manager - Pharma Labs
ThermoFisher Scientific
Posted 5 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Sr Project Manager - Pharma Labs**
**Remote opportunity**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
As a Senior Project Manager you will work for our GMP Labs in Athlone where we provide analytical services to our clients. You would have responsibility for managing and direct oversight for a portfolio of projects for a specific client and be accountable for overall project/portfolio performance.
**A day in the Life:**
+ Proactively identifies resources and budgets projects
+ Prioritizes client's portfolio in line with site-wide portfolio of projects and is the primaryoperational interface between the business and the client.
+ Negotiates and makes real-time decisions with the client.
+ Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement.
+ Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.
+ Provides oversight and coordination of client portfolio. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, this requires negotiating and real time decision making with the client.
+ Facilitates the flow of technical and clinical laboratory information to all stakeholders
+ Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the project
+ Prepares the project specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated project master file with version controls for specs, budgets and contracts.
**Keys to Success:**
**Education** **& Experience**
+ Bachelor's in a scientific discipline
+ 8+ years experience in (pharmaceutical) project management
+ Executive level presentation experience
**Knowledge, Skills, Abilities**
+ Strong science and/or business acumen
+ Strong verbal, written and presentation skills
+ Superior time management, planning, and organizational skills
+ Proven analytical skills
+ Demonstrated compliance with procedures and policies
+ Ability to perform multiple tasks effectively in a stressful environment
+ Extensive knowledge and experience in Project Management
+ Strong client relationship management skills
+ Ability to work effectively with multi-level teams
+ Ability to work in a fast-paced undefined environment
+ Strong negotiation skills
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Sr Project Manager - Pharma Labs**
**Remote opportunity**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
As a Senior Project Manager you will work for our GMP Labs in Athlone where we provide analytical services to our clients. You would have responsibility for managing and direct oversight for a portfolio of projects for a specific client and be accountable for overall project/portfolio performance.
**A day in the Life:**
+ Proactively identifies resources and budgets projects
+ Prioritizes client's portfolio in line with site-wide portfolio of projects and is the primaryoperational interface between the business and the client.
+ Negotiates and makes real-time decisions with the client.
+ Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement.
+ Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.
+ Provides oversight and coordination of client portfolio. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, this requires negotiating and real time decision making with the client.
+ Facilitates the flow of technical and clinical laboratory information to all stakeholders
+ Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the project
+ Prepares the project specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated project master file with version controls for specs, budgets and contracts.
**Keys to Success:**
**Education** **& Experience**
+ Bachelor's in a scientific discipline
+ 8+ years experience in (pharmaceutical) project management
+ Executive level presentation experience
**Knowledge, Skills, Abilities**
+ Strong science and/or business acumen
+ Strong verbal, written and presentation skills
+ Superior time management, planning, and organizational skills
+ Proven analytical skills
+ Demonstrated compliance with procedures and policies
+ Ability to perform multiple tasks effectively in a stressful environment
+ Extensive knowledge and experience in Project Management
+ Strong client relationship management skills
+ Ability to work effectively with multi-level teams
+ Ability to work in a fast-paced undefined environment
+ Strong negotiation skills
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
5
2026 Graduate Quality Control Analyst
Ringaskiddy, Munster
J&J Family of Companies
Posted 5 days ago
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Professional
**All Job Posting Locations:**
Ringaskiddy, Cork, Ireland
**Job Description:**
**Position:** Graduate Quality Control Analyst
**Start Date:** September 2026
**Location:** Cork, Ireland
**Johnson & Johnson Innovative Medicine** established its operation in Ringaskiddy in 2005 on a 100-acre site with an investment of 500 million. For more than 25 years we have been a global leader in the field of biomedicines, particularly in groundbreaking monoclonal antibody technology, an approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is fully operational and currently expanding its operations to continue focusing on producing biomedicines for both the treatment of immune related diseases and new and creative cancer treatments.
**ABOUT THE JOHNSON & JOHNSON GRADUATE PROGRAMME**
The Graduate Programme is a collaborative programme across the Johnson & Johnson Campus Ireland Sites. It is aimed at high potential individuals who, when given the right tools, are empowered to proactively take responsibility, effect change and make a positive contribution to their teams and the business.
**THE SUCCESSFUL CANDIDATE WILL HAVE THE OPPORTUNITY TO:**
+ Develop relevant technical skills within their area of expertise.
+ Experience cross functional exposure both on site and within Campus Ireland.
+ Participate in regular one to ones and feedback to support your on-going development.
+ Engage in personal development and effectiveness training.
+ Develop influencing & communication skills.
+ Gain Project Management experience.
+ Learn new and innovative technologies.
+ Gain exposure to Senior Management Team.
+ Participate in continuous professional development program with a recognised qualification.
**JOB PURPOSE:**
We have an exciting opportunity for a QC Analyst on the Ireland Graduate Program. This individual will be responsible for carrying out tasks and projects related to the analysis of biotechnology products as required by Good Manufacturing practice (GMP). The individual will participate in the delivery of lab testing efforts by using both existing and new procedures or processes to independently interpret data and identify and correct issues. Proposes ideas and next steps to supervisors and/or managers. Receives intermittent, moderately detailed instructions from Quality leaders at various levels, in addition to other partners.
**WHAT YOU'RE GREAT AT:**
+ Analytical testing knowledge including an understanding of Biopharmaceutical manufacturing and batch release processes.
+ Knowledge of equipment qualification, analytical method transfers, root cause problem solving and continuous improvement desirable.
+ A strong teammate who is very customer focused, possesses leadership and testing skills and both stakeholder and project management experience.
+ Strong collaboration & interpersonal skills, both written and oral.
**AS A QC ANALYST YOUR TYPICAL DAY MAY INCLUDE:**
+ Supporting the QC Team Leader during day to day operations of area.
+ Testing for laboratory related projects e.g. analytical method transfers, equipment qualification, invalid assay and NC reduction initiatives etc.
+ Performing IP/ Microbiology/ Bioassay/ Separations analysis.
+ Identifying and implementing laboratory process improvements leading to improved efficiency &/or compliance within area.
+ Authors and investigates internal investigations, participates in regulatory inspections & external technical discussions etc.
+ Keeping up to date with analytical technology and regulatory / compliance trends.
+ Participates in technical groups to implement laboratory activities while following local and global regulatory requirements as well as J&J standards.
+ Supports the roll-out of laboratory activities (for example, instrument life-cycle management).
+ Performs laboratory studies, projects, and processes/initiatives.
+ Assists in developing lab strategies, policies, and guidelines linked to area of expertise (for example, authoring Standard Operating Procedures).
+ Contributes to external and/or internal manuscripts, regulatory reports, and technical reports.
+ Supports equipment qualifications to ensure accuracy and consistency of results.
**QUALIFICATIONS**
**Education and Experience:**
+ Minimum Bachelors degree in Chemistry, Biochemistry or related Scientific discipline.
+ Recent graduate (2025 or due to graduate in 2026).
+ Technical troubleshooting and problem-solving skills.
+ Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
+ Be ambitious with excellent social, communication and partner management skills.
+ Acute attention to detail.
+ A focus on patients and customers at all times.
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Professional
**All Job Posting Locations:**
Ringaskiddy, Cork, Ireland
**Job Description:**
**Position:** Graduate Quality Control Analyst
**Start Date:** September 2026
**Location:** Cork, Ireland
**Johnson & Johnson Innovative Medicine** established its operation in Ringaskiddy in 2005 on a 100-acre site with an investment of 500 million. For more than 25 years we have been a global leader in the field of biomedicines, particularly in groundbreaking monoclonal antibody technology, an approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is fully operational and currently expanding its operations to continue focusing on producing biomedicines for both the treatment of immune related diseases and new and creative cancer treatments.
**ABOUT THE JOHNSON & JOHNSON GRADUATE PROGRAMME**
The Graduate Programme is a collaborative programme across the Johnson & Johnson Campus Ireland Sites. It is aimed at high potential individuals who, when given the right tools, are empowered to proactively take responsibility, effect change and make a positive contribution to their teams and the business.
**THE SUCCESSFUL CANDIDATE WILL HAVE THE OPPORTUNITY TO:**
+ Develop relevant technical skills within their area of expertise.
+ Experience cross functional exposure both on site and within Campus Ireland.
+ Participate in regular one to ones and feedback to support your on-going development.
+ Engage in personal development and effectiveness training.
+ Develop influencing & communication skills.
+ Gain Project Management experience.
+ Learn new and innovative technologies.
+ Gain exposure to Senior Management Team.
+ Participate in continuous professional development program with a recognised qualification.
**JOB PURPOSE:**
We have an exciting opportunity for a QC Analyst on the Ireland Graduate Program. This individual will be responsible for carrying out tasks and projects related to the analysis of biotechnology products as required by Good Manufacturing practice (GMP). The individual will participate in the delivery of lab testing efforts by using both existing and new procedures or processes to independently interpret data and identify and correct issues. Proposes ideas and next steps to supervisors and/or managers. Receives intermittent, moderately detailed instructions from Quality leaders at various levels, in addition to other partners.
**WHAT YOU'RE GREAT AT:**
+ Analytical testing knowledge including an understanding of Biopharmaceutical manufacturing and batch release processes.
+ Knowledge of equipment qualification, analytical method transfers, root cause problem solving and continuous improvement desirable.
+ A strong teammate who is very customer focused, possesses leadership and testing skills and both stakeholder and project management experience.
+ Strong collaboration & interpersonal skills, both written and oral.
**AS A QC ANALYST YOUR TYPICAL DAY MAY INCLUDE:**
+ Supporting the QC Team Leader during day to day operations of area.
+ Testing for laboratory related projects e.g. analytical method transfers, equipment qualification, invalid assay and NC reduction initiatives etc.
+ Performing IP/ Microbiology/ Bioassay/ Separations analysis.
+ Identifying and implementing laboratory process improvements leading to improved efficiency &/or compliance within area.
+ Authors and investigates internal investigations, participates in regulatory inspections & external technical discussions etc.
+ Keeping up to date with analytical technology and regulatory / compliance trends.
+ Participates in technical groups to implement laboratory activities while following local and global regulatory requirements as well as J&J standards.
+ Supports the roll-out of laboratory activities (for example, instrument life-cycle management).
+ Performs laboratory studies, projects, and processes/initiatives.
+ Assists in developing lab strategies, policies, and guidelines linked to area of expertise (for example, authoring Standard Operating Procedures).
+ Contributes to external and/or internal manuscripts, regulatory reports, and technical reports.
+ Supports equipment qualifications to ensure accuracy and consistency of results.
**QUALIFICATIONS**
**Education and Experience:**
+ Minimum Bachelors degree in Chemistry, Biochemistry or related Scientific discipline.
+ Recent graduate (2025 or due to graduate in 2026).
+ Technical troubleshooting and problem-solving skills.
+ Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
+ Be ambitious with excellent social, communication and partner management skills.
+ Acute attention to detail.
+ A focus on patients and customers at all times.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Specialist Regulatory Affairs
Cootehill, Ulster
Abbott
Posted 5 days ago
Job Viewed
Job Description
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Abbott in Ireland**
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
WHAT YOU'LL DO
**Responsibilities:**
- Regulatory project management for global programs (PIERs, Global Science Innovation, Supply Network, Strategic) without close supervision by manager.
- Lead strategic programs with supervision by manager.
- Develop and execute regulatory strategies to ensure successful registration and approval of international nutrition products.
- Represent Abbott Nutrition regulatory affairs on departmental and divisional teams, providing timely regulatory input and communication to ensure regulatory requirements are met.
- Analyse and identify regulatory requirements against project needs.
- Communicate registration needs before and during product development.
- Prepare options, suggestions, and/or a regulatory assessment for product registration to achieve global project goals.
- Execute plans, complete tasks according to priorities set by Manager, align work with business goals and align actions with agreed upon strategies.
- Excellent verbal and written communication skills and ability to effectively present scientific data to management.
- Assure established policies and standard interpretations of regulations are followed for assigned projects. Maintain an awareness of legislation and assess impact on Abbott business.
- Responsible for tracking and timely completion of regulatory assignments, registration assessments, and execution of filing
- Responsible for effective communication of regulatory requirements to project teams and internal customers (scientists, marketing, quality assurance, product development, affiliates).
- Accountable for compliance with internal SOPs and understanding & compliance with relevant Regulations.
- Position is highly visible to internal and external stakeholders.
**EDUCATION AND EXPERIENCE, YOU'LL BRING**
**Required:**
- Bachelor's degree is required (engineering, nutrition, chemistry or biological science is
preferred)
- 3 or more years of relevant experience (exposure to regulatory affairs is preferred)
- Project management experience and/or exposure to project management principles.
- High level of effective verbal and written communication skills, including ability to negotiate,
influence, and manage conflict.
- Able to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates, etc.) to solve problems and communicate regulatory needs.
**Preferred:**
- Master's degree.
- Prior regulatory experience in the food industry.
- Knowledge of regulations relating to foods, infant formula manufacturing and/or consumer products.
- Manufacturing/Quality/Packaging or similar experience.
Connect with us at and on LinkedIn , Facebook , Instagram , X and YouTube .
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Abbott in Ireland**
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
WHAT YOU'LL DO
**Responsibilities:**
- Regulatory project management for global programs (PIERs, Global Science Innovation, Supply Network, Strategic) without close supervision by manager.
- Lead strategic programs with supervision by manager.
- Develop and execute regulatory strategies to ensure successful registration and approval of international nutrition products.
- Represent Abbott Nutrition regulatory affairs on departmental and divisional teams, providing timely regulatory input and communication to ensure regulatory requirements are met.
- Analyse and identify regulatory requirements against project needs.
- Communicate registration needs before and during product development.
- Prepare options, suggestions, and/or a regulatory assessment for product registration to achieve global project goals.
- Execute plans, complete tasks according to priorities set by Manager, align work with business goals and align actions with agreed upon strategies.
- Excellent verbal and written communication skills and ability to effectively present scientific data to management.
- Assure established policies and standard interpretations of regulations are followed for assigned projects. Maintain an awareness of legislation and assess impact on Abbott business.
- Responsible for tracking and timely completion of regulatory assignments, registration assessments, and execution of filing
- Responsible for effective communication of regulatory requirements to project teams and internal customers (scientists, marketing, quality assurance, product development, affiliates).
- Accountable for compliance with internal SOPs and understanding & compliance with relevant Regulations.
- Position is highly visible to internal and external stakeholders.
**EDUCATION AND EXPERIENCE, YOU'LL BRING**
**Required:**
- Bachelor's degree is required (engineering, nutrition, chemistry or biological science is
preferred)
- 3 or more years of relevant experience (exposure to regulatory affairs is preferred)
- Project management experience and/or exposure to project management principles.
- High level of effective verbal and written communication skills, including ability to negotiate,
influence, and manage conflict.
- Able to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates, etc.) to solve problems and communicate regulatory needs.
**Preferred:**
- Master's degree.
- Prior regulatory experience in the food industry.
- Knowledge of regulations relating to foods, infant formula manufacturing and/or consumer products.
- Manufacturing/Quality/Packaging or similar experience.
Connect with us at and on LinkedIn , Facebook , Instagram , X and YouTube .
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
7
Senior Clinical Data Team Lead (Senior DTL) - FSP
Dublin, Leinster
IQVIA
Posted 5 days ago
Job Viewed
Job Description
The Sr. CDM will lead and contribute to data management activities in support of Client's studies across all stages of clinical drug development.
**Summary of Key Responsibilities**
+ Contribute to data management activities as a lead study data manager in support of Client's clinical studies
+ Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
+ Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
+ Oversight of database lock activities and ultimate archiving of study data
+ Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
+ Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
+ Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
+ Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
+ Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
+ Participate in the training of external vendors and site staff
+ Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
+ Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
+ Support GCP inspection readiness
**Qualifications**
+ BS/BA in scientific discipline,
+ At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
+ Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
+ Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
+ Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
+ Experience working with Medidata Rave
+ Experience using standardized medical terminology, including MedDRA and WHODrug
+ Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
+ Excellent written and oral communications skills
+ Highly motivated and flexible, with excellent organizational and time management skills
+ Ability to work independently and as part of a multi-disciplinary team
+ Understanding of ICH GCP as well as general knowledge of industry practices and standards
+ Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
+ NDA/MAA experience
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
**Summary of Key Responsibilities**
+ Contribute to data management activities as a lead study data manager in support of Client's clinical studies
+ Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
+ Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
+ Oversight of database lock activities and ultimate archiving of study data
+ Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
+ Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
+ Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
+ Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
+ Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
+ Participate in the training of external vendors and site staff
+ Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
+ Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
+ Support GCP inspection readiness
**Qualifications**
+ BS/BA in scientific discipline,
+ At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
+ Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
+ Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
+ Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
+ Experience working with Medidata Rave
+ Experience using standardized medical terminology, including MedDRA and WHODrug
+ Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
+ Excellent written and oral communications skills
+ Highly motivated and flexible, with excellent organizational and time management skills
+ Ability to work independently and as part of a multi-disciplinary team
+ Understanding of ICH GCP as well as general knowledge of industry practices and standards
+ Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
+ NDA/MAA experience
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.
8
Director, Quality & Regulatory
Galway, Connacht
Medtronic
Posted 5 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Medtronic is hiring a Quality System Director. The person is Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
**Responsibilities may include the following and other duties may be assigned:**
-Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
-Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
-Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
-Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
-Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
-Co-ordinates legal requests in support of government investigations or litigations.
-Ensures the quality assurance programs and policies are maintained and modified regularly.
-Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
**Required Knowledge and Experience:**
-Autonomy: Manages department (s) or small unit that includes multiple teams led by managers and / or supervisors. Provides motivational leadership for the area managed. Provides thought and technical leadership. Performs work without appreciable direction.
-Organizational Impact: Leads the development of the strategy for own department or business area, ensuring links to the company's aims and objectives. Management authority to make large business decisions and some strategic decisions. Decisions impact the financial performance, employees, or public image of the operational unit and/or company. Typically has budget or P&L accountability for a department, broad functional area or geography.
-Innovation and Complexity: Drives innovation across the business area, encouraging best practice and knowledge sharing. Significantly improves, changes or adapts own department or business area's processes, systems, products or services. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
-Communication and Influence: Develops long term strategic relationships and alliances with key internal and external stakeholders. Communicates and conducts briefings with senior or executive leadership regarding ongoing operations and strategic initiatives. Influences across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives.
-Leadership and Talent Management Directs and leads a department, broad functional area or geography, including one or more teams led by managers and / or supervisors. Determines supervisory relationships and creates workforce and staffing plans to accomplish business results. Authorizes hiring, firing, Job Description promotion and reward within own area.
-Requires broad management and leadership knowledge to lead multiple job areas, and detailed functional and operational expertise. Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
Medtronic is hiring a Quality System Director. The person is Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
**Responsibilities may include the following and other duties may be assigned:**
-Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
-Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
-Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
-Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
-Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
-Co-ordinates legal requests in support of government investigations or litigations.
-Ensures the quality assurance programs and policies are maintained and modified regularly.
-Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
**Required Knowledge and Experience:**
-Autonomy: Manages department (s) or small unit that includes multiple teams led by managers and / or supervisors. Provides motivational leadership for the area managed. Provides thought and technical leadership. Performs work without appreciable direction.
-Organizational Impact: Leads the development of the strategy for own department or business area, ensuring links to the company's aims and objectives. Management authority to make large business decisions and some strategic decisions. Decisions impact the financial performance, employees, or public image of the operational unit and/or company. Typically has budget or P&L accountability for a department, broad functional area or geography.
-Innovation and Complexity: Drives innovation across the business area, encouraging best practice and knowledge sharing. Significantly improves, changes or adapts own department or business area's processes, systems, products or services. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
-Communication and Influence: Develops long term strategic relationships and alliances with key internal and external stakeholders. Communicates and conducts briefings with senior or executive leadership regarding ongoing operations and strategic initiatives. Influences across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives.
-Leadership and Talent Management Directs and leads a department, broad functional area or geography, including one or more teams led by managers and / or supervisors. Determines supervisory relationships and creates workforce and staffing plans to accomplish business results. Authorizes hiring, firing, Job Description promotion and reward within own area.
-Requires broad management and leadership knowledge to lead multiple job areas, and detailed functional and operational expertise. Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
9