Ireland offers a dynamic landscape for medical professionals, with opportunities in hospitals, clinics, and 194 Medical jobs in Ireland
Senior Medical Safety Analyst
Sligo, Connacht
Abbott
Posted 3 days ago
Job Viewed
Job Description
**FIXED TERM CONTRACT**
**Abbott in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As an individual contributor, with guidance from manager/team, functions to support Medical Safety & Surveillance (MSS) by reviewing, assessing, and summarizing medical device complaint information for complex investigations and risk assessments. Critically assess aggregate safety data from medical devices and communicates findings to internal stakeholders. Independently creates and delivers device medical safety training to a Global audience. Drafts documentation, including data reviews, clinical evaluations, literature reviews and standard operating procedures.
**MAJOR RESPONSIBILITIES**
+ Create and present medical safety related analyses, reports, and/or assessments orally and/or in writing within/ outside the Medical Safety and Surveillance department
+ Gather, critically analyze, and present findings from Medical Safety and Surveillance complaint data on a periodic basis. Including tracking and trending activities.
+ Ensures adherence to departmental standard operating procedures (SOPs), and draft new SOP as needed.
+ Comfortable developing Medical Safety and Surveillance training materials and have strong presentation skills to provide training to a broad international audience.
+ May write or assist in preparing, completing literature or website searches and data analysis for regulatory documentation supporting medical device registration.
+ Conduct periodic literature searches, summarize findings and present information to a cross-functional team.
+ Will act as a back up to colleagues on day-to-day medical device complaints processing and conduct medical follow up calls to customers as needed to obtain adverse event and/or complaint details
+ As needed, determine complaint reportability to the competent authority; drive on-time vigilance reporting within regulatory time-frames
+ Other duties/projects/support as assigned.
**EDUCATION & COMPETENCIES**
+ Bachelor of Science, a Health science related background is a plus, such as dietitian, pharmacist, nurse etc.
+ RAC certification a plus
+ 2-3 years Medical Device experience in activities such as aggregate data review, Risk Assessment, DFMEA review, and patient safety
+ Data analytics / strong excel, PowerBI and/or data visualization skills
+ Medical knowledge to apply critical thinking and data analysis to Medical Safety data and/or Medical Device risk assessments.
+ Basic understanding of Global Medical Device regulations (primarily EUMDR, MedDEV), clinical research, and international guidelines/ standards related to medical devices (ISO, GSPR, MDGC etc.)
+ Willingness to learn other applicable Medical Device regulations, standards and guidelines
+ Drive to adhere to standard operating procedures (SOPs)
+ Strong ability /experience in presenting medical and scientific training/ data orally and in writing
+ Computer proficient (Windows, Word, Excel)
+ Enjoys working in a collaborative environment and with a multidisciplinary, Global team.
+ Works independently
Connect with us at , on LinkedIn at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
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 in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As an individual contributor, with guidance from manager/team, functions to support Medical Safety & Surveillance (MSS) by reviewing, assessing, and summarizing medical device complaint information for complex investigations and risk assessments. Critically assess aggregate safety data from medical devices and communicates findings to internal stakeholders. Independently creates and delivers device medical safety training to a Global audience. Drafts documentation, including data reviews, clinical evaluations, literature reviews and standard operating procedures.
**MAJOR RESPONSIBILITIES**
+ Create and present medical safety related analyses, reports, and/or assessments orally and/or in writing within/ outside the Medical Safety and Surveillance department
+ Gather, critically analyze, and present findings from Medical Safety and Surveillance complaint data on a periodic basis. Including tracking and trending activities.
+ Ensures adherence to departmental standard operating procedures (SOPs), and draft new SOP as needed.
+ Comfortable developing Medical Safety and Surveillance training materials and have strong presentation skills to provide training to a broad international audience.
+ May write or assist in preparing, completing literature or website searches and data analysis for regulatory documentation supporting medical device registration.
+ Conduct periodic literature searches, summarize findings and present information to a cross-functional team.
+ Will act as a back up to colleagues on day-to-day medical device complaints processing and conduct medical follow up calls to customers as needed to obtain adverse event and/or complaint details
+ As needed, determine complaint reportability to the competent authority; drive on-time vigilance reporting within regulatory time-frames
+ Other duties/projects/support as assigned.
**EDUCATION & COMPETENCIES**
+ Bachelor of Science, a Health science related background is a plus, such as dietitian, pharmacist, nurse etc.
+ RAC certification a plus
+ 2-3 years Medical Device experience in activities such as aggregate data review, Risk Assessment, DFMEA review, and patient safety
+ Data analytics / strong excel, PowerBI and/or data visualization skills
+ Medical knowledge to apply critical thinking and data analysis to Medical Safety data and/or Medical Device risk assessments.
+ Basic understanding of Global Medical Device regulations (primarily EUMDR, MedDEV), clinical research, and international guidelines/ standards related to medical devices (ISO, GSPR, MDGC etc.)
+ Willingness to learn other applicable Medical Device regulations, standards and guidelines
+ Drive to adhere to standard operating procedures (SOPs)
+ Strong ability /experience in presenting medical and scientific training/ data orally and in writing
+ Computer proficient (Windows, Word, Excel)
+ Enjoys working in a collaborative environment and with a multidisciplinary, Global team.
+ Works independently
Connect with us at , on LinkedIn at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
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.
0
Medical Devices Global Regulatory Documentation Manager
Sligo, Connacht
Abbott
Posted 3 days ago
Job Viewed
Job Description
**FIXED TERM CONTRACT**
**Abbott in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will use his/her in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. The MSS Global Medical Device Manager will have responsibility for generating documentation that supports Abbott Nutrition's global medical device registration and on-going compliance with EUMDR. This may include development and implementation of global standardized operating procedures. The candidate may also lead the development/maintenance of local medical device vigilance systems (predominantly for UK and EU), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a medical device subject matter expert within the company.
**MAJOR RESPONSIBILITIES**
+ Organizes, manages and maintains a highly compliant global medical device system for Abbott Nutrition.
+ Maintains awareness and ensures compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.
+ Develops and implements training programs for individuals involved in medical device activities.
+ Monitors medical device system performance; tracks compliance metrics and reports to global MSS Leadership Team.
+ Ensures global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings.
+ Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
+ Reviews and provides input to product DFMEAs.
+ Assists local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable.
+ Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.
+ Assists in the preparation, review and submission of aggregate safety reports.
+ Accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division.
**EDUCATION & COMPETENCIES**
+ Master's degree in related health science or equivalent skills, education, or experience.
+ RAC certification is a plus.
+ 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).
+ Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
+ Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus.
+ Knowledge of Vigilance reporting regulations on a Global scale.
+ Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
+ Fluency in spoken/written English;
+ Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
+ Excellent communication and interpersonal skills, both written and spoken.
+ Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects.
+ Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
+ High level of accountability and reliability.
+ Demonstrates ability to work productively as a team.
+ Ability to work in a fast paced, changing environment.
+ Ease of operating in high stress, big decision situations.
+ Continuous improvement mindset.
+ Ability to influence a team in a positive way in relation to performance, change, and culture.
+ Demonstrate broad knowledge of Abbott's business and how department processes/responsibilities interconnect.
+ Mastery of the inventory deployment planning process.
+ Exceptional problem-solving skills
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 in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will use his/her in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. The MSS Global Medical Device Manager will have responsibility for generating documentation that supports Abbott Nutrition's global medical device registration and on-going compliance with EUMDR. This may include development and implementation of global standardized operating procedures. The candidate may also lead the development/maintenance of local medical device vigilance systems (predominantly for UK and EU), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a medical device subject matter expert within the company.
**MAJOR RESPONSIBILITIES**
+ Organizes, manages and maintains a highly compliant global medical device system for Abbott Nutrition.
+ Maintains awareness and ensures compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.
+ Develops and implements training programs for individuals involved in medical device activities.
+ Monitors medical device system performance; tracks compliance metrics and reports to global MSS Leadership Team.
+ Ensures global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings.
+ Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
+ Reviews and provides input to product DFMEAs.
+ Assists local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable.
+ Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.
+ Assists in the preparation, review and submission of aggregate safety reports.
+ Accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division.
**EDUCATION & COMPETENCIES**
+ Master's degree in related health science or equivalent skills, education, or experience.
+ RAC certification is a plus.
+ 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).
+ Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
+ Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus.
+ Knowledge of Vigilance reporting regulations on a Global scale.
+ Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
+ Fluency in spoken/written English;
+ Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
+ Excellent communication and interpersonal skills, both written and spoken.
+ Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects.
+ Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
+ High level of accountability and reliability.
+ Demonstrates ability to work productively as a team.
+ Ability to work in a fast paced, changing environment.
+ Ease of operating in high stress, big decision situations.
+ Continuous improvement mindset.
+ Ability to influence a team in a positive way in relation to performance, change, and culture.
+ Demonstrate broad knowledge of Abbott's business and how department processes/responsibilities interconnect.
+ Mastery of the inventory deployment planning process.
+ Exceptional problem-solving skills
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.
1
Internal Medical Translator - English to German (home-based, m/w/d)
Dublin, Leinster
IQVIA
Posted 3 days ago
Job Viewed
Job Description
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (German)
+ Fluency in source language (English)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
#LI-remote
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 .
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
IQVIA 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
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (German)
+ Fluency in source language (English)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
#LI-remote
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 .
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
IQVIA 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.
2
Internal Medical Translator, Hebrew to English & English to Hebrew
Dublin, Leinster
IQVIA
Posted 3 days ago
Job Viewed
Job Description
**Internal Medical Translator, Hebrew to English & English to Hebrew**
EMEA: Home-based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (Hebrew or English)
+ Fluency in source language (Hebrew or English)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools (preferably MemoQ)
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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
EMEA: Home-based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (Hebrew or English)
+ Fluency in source language (Hebrew or English)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools (preferably MemoQ)
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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.
3
Internal Medical Translator - Korean to English
Dublin, Leinster
IQVIA
Posted 3 days ago
Job Viewed
Job Description
Internal Medical Translator/In-house Linguist (Korean to English)
Location: EMEA - Home-Based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (English Native, Fluent Korean)
+ Fluency in source language(s)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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 .
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
IQVIA 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
Location: EMEA - Home-Based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (English Native, Fluent Korean)
+ Fluency in source language(s)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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 .
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
IQVIA 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.
4
Internal Medical Translator - Japanese to English
Dublin, Leinster
IQVIA
Posted 3 days ago
Job Viewed
Job Description
Internal Medical Translator/In-house Linguist (Japanese to English)
Location: EMEA - Home-Based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (English Native, Fluent Japanese)
+ Fluency in source language(s)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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
Location: EMEA - Home-Based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (English Native, Fluent Japanese)
+ Fluency in source language(s)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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.
5
Internal Medical Translator - English to German
Dublin, Leinster
IQVIA
Posted 3 days ago
Job Viewed
Job Description
Internal Medical Translator/In-house Linguist (English to German)
Location: EMEA - Home-Based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (German Native, Fluent English)
+ Fluency in source language(s)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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
Location: EMEA - Home-Based
**Unlock Your Potential with IQVIA Language Solutions!**
At IQVIA Language Solutions, we stand out as the only 100% language solutions provider dedicated to transforming the way the life sciences industry communicates and improve patients' lives.
We foster a meaningful, engaging and rewarding environment that sets us apart.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
With a proven track record serving pharmaceutical, biotech companies and CROs, we empower clients to navigate challenges from clinical trials to commercialization, accelerating the delivery of new treatments and ultimately having a positive impact on patients all over the world.
Joining IQVIA Language Solutions means becoming part of a dynamic team within the broader IQVIA network-a global leader in clinical research services, commercial insights, and healthcare intelligence.
We prioritize innovation and collaboration, enabling you to thrive while making a meaningful impact in life sciences and healthcare.
Ready to embark on this transformative journey? Explore our open positions and help shape the future of language solutions in life sciences!
**Job Overview:**
The Internal Translator is responsible for linguistically and culturally interpreting written material in a way that maintains or duplicates the structure and style of the original text, while keeping the ideas and facts of the original material accurate.
You will be fluent in two or more languages and skills that allows you to research industry-specific terminology, whilst possessing a strong commitment to quality and accuracy and show outstanding problem-solving skills when faced with difficult content and instruction.
You will also build strong relationships with the IQVIA Translations Services team and will play a key role in the effectiveness and success of IQVIA Translations Services operations, by working with them to update or improve glossaries, Translation Memories, Style Guides, and any other internal asset, and identify gaps in instructions or any external issue that may affect the commitment to the client.
Coupled with being a strategic partner in delivering translations on time and adhering to our quality commitments to clients, you will also proofread translated texts for terminology, grammar, spelling, and punctuation accuracy.
**Requirements:**
+ Native speaker in advertised targeted language (German Native, Fluent English)
+ Fluency in source language(s)
+ At least 3 years of experience translating, reviewing, and editing life sciences content, including clinical trial documents
+ A tertiary or university degree in translation or linguistics and at least 3 years of translation experience OR no university degree and at least 5 years of translation experience
+ Experience with translation management systems and CAT tools
**Join IQVIA and let's create a healthier world together:**
+ Access to new, innovative technologies
+ Work within a collaborative and vibrant environment
+ Own your career!
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
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.
Be The First To Know
About the latest Medical Jobs in Ireland !
6
Medical Director, Laboratory
Dublin, Leinster
ICON Clinical Research
Posted 3 days ago
Job Viewed
Job Description
Medical Director, Ireland
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**Medical Director, ICL**
**Job Profile Summary**
ICON Clinical Laboratories is seeking a US - or EU-based Medical Director to join our Medical Affairs team supporting clinical trial testing globally. The individual filling this position may act as a license holder for more than one ICL laboratory and must be qualified by training and experience to fulfill the duties and responsibilities for a Director of a High Complexity Laboratory as defined by the College of American Pathologists.
Our laboratories hold both CAP and ISO15189 certifications as appropriate. Responsibilities include providing clinical and operational leadership to ensure that clinical, regulatory, quality, and patient and staff safety standards are met, as well as addressing specific requests for individual trial sponsors. Individuals with a specialty and licensure in Clinical Chemistry or Biochemistry are especially desirable
**The role:**
As the Medical Director of a High Complexity Clinical Laboratory, you are responsible for the overall oversight, management, and direction of medical and scientific aspects of the laboratory operations. This role ensures compliance with all regulatory and accreditation requirements, guides clinical decision-making, and ensures that the laboratory's testing services meet the highest standards of quality and patient care. Of note, many of the operational roles listed below can be delegated. Those that cannot be delegated, such as the Annual Safety Inspection and the review of Proficiency, must be performed by the Medical Director.
Key Responsibilities include
**Medical Oversight & Leadership:**
+ Provide clinical oversight and medical guidance for laboratory testing, ensuring all results and diagnoses are accurate and medically appropriate.
+ Oversee the laboratory's clinical activities to ensure patient safety and proper diagnostic procedures.
+ Interpret test results, provide clinical consultation, and collaborate with other healthcare providers on test selections, result interpretations, and treatment plans.
+ Stay informed about new medical advancements, technologies, and testing methodologies relevant to high-complexity clinical laboratories.
**Regulatory Compliance & Accreditation:**
+ Ensure compliance with all relevant federal, state, and local regulations, including but not limited to CLIA (Clinical Laboratory Improvement Amendments), CAP (College of American Pathologists), and Joint Commission standards.
+ Maintain laboratory accreditation by ensuring adherence to appropriate guidelines and policies.
+ Prepare for and lead regulatory inspections and audits.
+ Establish and enforce policies for quality control, quality assurance, and proficiency testing.
**Staff Development & Training:**
+ Oversee the recruitment, training, and performance evaluation of laboratory personnel.
+ Provide medical and scientific training to laboratory staff and ensure they are up to date with current best practices.
+ Foster a culture of continuous learning, professional development, and high-quality patient care among laboratory personnel.
**Quality Assurance & Improvement:**
+ Lead the implementation and oversight of quality assurance programs and initiatives such as the ICL Global QC Harmonization scheme and the monthly monitoring of KPI's at each lab.
+ Monitor laboratory performance and implement improvements based on data-driven insights.
+ Lead root cause analysis and corrective action plans in response to any non-conformance, errors, or patient safety incidents.
+ Lead risk management efforts, including identifying and mitigating risks related to laboratory testing, patient safety, and data integrity.
+ Develop and implement protocols for addressing adverse events or near-miss incidents in the laboratory.
**Clinical Consultation & Collaboration:**
+ Consistent with training and professional experience, provides scientific, technical and/or medical expertise to other departments within ICON laboratories including the specialty laboratory, project management, and business development departments. This expertise will include the interpretation, correlation and communication of the medical significance of laboratory data.
+ Provide professional, scientific, consultative or advisory, organizational, administrative and educational matters relevant to the services offered.
.
**Operational Leadership:**
+ Work with laboratory leadership to develop strategies and goals for the laboratory's operation and growth.
+ Assist in resource allocation, budgeting, and financial planning for the laboratory, ensuring efficient use of resources while maintaining high-quality services.
+ Evaluate and recommend new technologies and laboratory equipment to improve testing services.
- Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance.
- Travel up to 15% of the time.
- Able to discharge the responsibilities described in Part 19.3© (1), (1) through (11) of 10 NYCRR (State of NY code of Rules and Regulations) and the College of American Pathologists' requirements (as stated in the "Laboratory Director Assessment" Inspection Checklist).
**Experience & Qualifications:**
**Education:**
+ MD or DO degree with a valid and unrestricted U.S. medical license.
+ Board-certified in Pathology, Clinical Pathology, or another relevant specialty (e.g., Medical Microbiology, Clinical Chemistry).
+ Additional qualifications or certifications in laboratory medicine are preferred (e.g., Clinical Laboratory Director certification)
**Experience:**
+ Minimum of 5 years of experience in a high-complexity clinical laboratory, with at least 2 years in a medical director role.
+ Proven track record of compliance with regulatory standards and accreditation processes (e.g., ISO15189, CLIA, CAP).
+ Experience in leading quality assurance, quality control, and patient safety programs.
This job description outlines the primary responsibilities and qualifications for the Medical Director of a High Complexity Clinical Laboratory. Duties may evolve over time, and additional responsibilities may be added as needed.
**Benefits of Working in ICON:**
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-SK1
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**Medical Director, ICL**
**Job Profile Summary**
ICON Clinical Laboratories is seeking a US - or EU-based Medical Director to join our Medical Affairs team supporting clinical trial testing globally. The individual filling this position may act as a license holder for more than one ICL laboratory and must be qualified by training and experience to fulfill the duties and responsibilities for a Director of a High Complexity Laboratory as defined by the College of American Pathologists.
Our laboratories hold both CAP and ISO15189 certifications as appropriate. Responsibilities include providing clinical and operational leadership to ensure that clinical, regulatory, quality, and patient and staff safety standards are met, as well as addressing specific requests for individual trial sponsors. Individuals with a specialty and licensure in Clinical Chemistry or Biochemistry are especially desirable
**The role:**
As the Medical Director of a High Complexity Clinical Laboratory, you are responsible for the overall oversight, management, and direction of medical and scientific aspects of the laboratory operations. This role ensures compliance with all regulatory and accreditation requirements, guides clinical decision-making, and ensures that the laboratory's testing services meet the highest standards of quality and patient care. Of note, many of the operational roles listed below can be delegated. Those that cannot be delegated, such as the Annual Safety Inspection and the review of Proficiency, must be performed by the Medical Director.
Key Responsibilities include
**Medical Oversight & Leadership:**
+ Provide clinical oversight and medical guidance for laboratory testing, ensuring all results and diagnoses are accurate and medically appropriate.
+ Oversee the laboratory's clinical activities to ensure patient safety and proper diagnostic procedures.
+ Interpret test results, provide clinical consultation, and collaborate with other healthcare providers on test selections, result interpretations, and treatment plans.
+ Stay informed about new medical advancements, technologies, and testing methodologies relevant to high-complexity clinical laboratories.
**Regulatory Compliance & Accreditation:**
+ Ensure compliance with all relevant federal, state, and local regulations, including but not limited to CLIA (Clinical Laboratory Improvement Amendments), CAP (College of American Pathologists), and Joint Commission standards.
+ Maintain laboratory accreditation by ensuring adherence to appropriate guidelines and policies.
+ Prepare for and lead regulatory inspections and audits.
+ Establish and enforce policies for quality control, quality assurance, and proficiency testing.
**Staff Development & Training:**
+ Oversee the recruitment, training, and performance evaluation of laboratory personnel.
+ Provide medical and scientific training to laboratory staff and ensure they are up to date with current best practices.
+ Foster a culture of continuous learning, professional development, and high-quality patient care among laboratory personnel.
**Quality Assurance & Improvement:**
+ Lead the implementation and oversight of quality assurance programs and initiatives such as the ICL Global QC Harmonization scheme and the monthly monitoring of KPI's at each lab.
+ Monitor laboratory performance and implement improvements based on data-driven insights.
+ Lead root cause analysis and corrective action plans in response to any non-conformance, errors, or patient safety incidents.
+ Lead risk management efforts, including identifying and mitigating risks related to laboratory testing, patient safety, and data integrity.
+ Develop and implement protocols for addressing adverse events or near-miss incidents in the laboratory.
**Clinical Consultation & Collaboration:**
+ Consistent with training and professional experience, provides scientific, technical and/or medical expertise to other departments within ICON laboratories including the specialty laboratory, project management, and business development departments. This expertise will include the interpretation, correlation and communication of the medical significance of laboratory data.
+ Provide professional, scientific, consultative or advisory, organizational, administrative and educational matters relevant to the services offered.
.
**Operational Leadership:**
+ Work with laboratory leadership to develop strategies and goals for the laboratory's operation and growth.
+ Assist in resource allocation, budgeting, and financial planning for the laboratory, ensuring efficient use of resources while maintaining high-quality services.
+ Evaluate and recommend new technologies and laboratory equipment to improve testing services.
- Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance.
- Travel up to 15% of the time.
- Able to discharge the responsibilities described in Part 19.3© (1), (1) through (11) of 10 NYCRR (State of NY code of Rules and Regulations) and the College of American Pathologists' requirements (as stated in the "Laboratory Director Assessment" Inspection Checklist).
**Experience & Qualifications:**
**Education:**
+ MD or DO degree with a valid and unrestricted U.S. medical license.
+ Board-certified in Pathology, Clinical Pathology, or another relevant specialty (e.g., Medical Microbiology, Clinical Chemistry).
+ Additional qualifications or certifications in laboratory medicine are preferred (e.g., Clinical Laboratory Director certification)
**Experience:**
+ Minimum of 5 years of experience in a high-complexity clinical laboratory, with at least 2 years in a medical director role.
+ Proven track record of compliance with regulatory standards and accreditation processes (e.g., ISO15189, CLIA, CAP).
+ Experience in leading quality assurance, quality control, and patient safety programs.
This job description outlines the primary responsibilities and qualifications for the Medical Director of a High Complexity Clinical Laboratory. Duties may evolve over time, and additional responsibilities may be added as needed.
**Benefits of Working in ICON:**
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-SK1
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
This advertiser has chosen not to accept applicants from your region.
7
Principal Medical Writer EMEA (Client-embedded)
ThermoFisher Scientific
Posted 8 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will 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.
**Summarized Purpose:**
We are excited to be expanding our Medical Writing FSP Team. We seeking a PMW dedicated to a client in the FSP space; preferred candidates will have experience in Structured Content Authoring systems and automation to support delivery. The ideal candidate will be experienced and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.
Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact-and where you're encouraged challenge yourself and contribute to breakthrough solutions , **the Principal Medical Writer role** could be a great fit.
**Key Responsibilities:**
+ Lead the development, writing, and editing ofcomplexclinical and regulatory documents.
+ Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure theaccurateandtimelycompletion of documents.
+ Ensure documentsalignwith regulatory guidelines, company standards, and industry best practices.
+ Provide strategic input and guidance on document content, structure, and presentation.
+ Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
+ Manage multiple writing projects simultaneously and prioritize tasks effectively.
+ Stay current with industry trends, guidelines, and regulatory requirements.
**Education and Experience:**
+ Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualificationrequired; Advanced degree preferred.
+ Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role(comparable to 8+ years in core Regulatory Medical Writer role capacity).
+ Experience working in the pharmaceutical/CRO industryrequired.
+ Experience in managing and directing complex medical writing projectsrequired.
+ Extensive experience in Phase 3 CSRs and/or protocol developmentrequired.
+ EU CTR experience preferred.
+ Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generationpreferred.
**Knowledge, Skills, and Abilities:**
+ Excellent organizational andprogram management skills.
+ Proven leadership skills to manage and mentor a team of medical writers.
+ Extensive knowledge ofregulatory guidelines and drug development processes.
+ Strong interpersonal and communication skills to build andmaintaineffective working relationships with colleagues and stakeholders.
+ Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards.
+ Self-motivated and adaptable.
+ Excellent judgment; high degree of independence in decision making and problem solving.
+ Capable of mentoring and leading junior level staff.
**What We Offer:**
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme ( , ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture ( , where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. 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**
At Thermo Fisher Scientific, you will 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.
**Summarized Purpose:**
We are excited to be expanding our Medical Writing FSP Team. We seeking a PMW dedicated to a client in the FSP space; preferred candidates will have experience in Structured Content Authoring systems and automation to support delivery. The ideal candidate will be experienced and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.
Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact-and where you're encouraged challenge yourself and contribute to breakthrough solutions , **the Principal Medical Writer role** could be a great fit.
**Key Responsibilities:**
+ Lead the development, writing, and editing ofcomplexclinical and regulatory documents.
+ Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure theaccurateandtimelycompletion of documents.
+ Ensure documentsalignwith regulatory guidelines, company standards, and industry best practices.
+ Provide strategic input and guidance on document content, structure, and presentation.
+ Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
+ Manage multiple writing projects simultaneously and prioritize tasks effectively.
+ Stay current with industry trends, guidelines, and regulatory requirements.
**Education and Experience:**
+ Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualificationrequired; Advanced degree preferred.
+ Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role(comparable to 8+ years in core Regulatory Medical Writer role capacity).
+ Experience working in the pharmaceutical/CRO industryrequired.
+ Experience in managing and directing complex medical writing projectsrequired.
+ Extensive experience in Phase 3 CSRs and/or protocol developmentrequired.
+ EU CTR experience preferred.
+ Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generationpreferred.
**Knowledge, Skills, and Abilities:**
+ Excellent organizational andprogram management skills.
+ Proven leadership skills to manage and mentor a team of medical writers.
+ Extensive knowledge ofregulatory guidelines and drug development processes.
+ Strong interpersonal and communication skills to build andmaintaineffective working relationships with colleagues and stakeholders.
+ Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards.
+ Self-motivated and adaptable.
+ Excellent judgment; high degree of independence in decision making and problem solving.
+ Capable of mentoring and leading junior level staff.
**What We Offer:**
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme ( , ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture ( , where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. 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.
8
Manager, Medical Device and Combination Product Quality Systems
Sligo, Connacht
AbbVie
Posted 8 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
9