11 Contract Medical Writer 12 Month Contract Ireland jobs in Ireland
Clinical Research Nurse (CNM II)- Cardiology
Posted 386 days ago
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Advisor/Sr. Advisor - Clinical Research Scientist - Neuroscience Clinical Development: Neuropsych...
Posted 3 days ago
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**Purpose:**
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Scientist - Clinical Development: Neuropsychologist is an integral member of the Neuroscience medical development team and participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
**Overall Responsibilities** **:**
With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. The clinical research scientist is a scientific resource for study teams, departments, and others as needed, particularly pertaining to the selection of clinical trial endpoints, the implementation and central monitoring strategy of clinical endpoints and the translation of clinical trial outcome data into meaningful benefits. This includes, but is not limited to, design and execution of phase 2/3 studies to address the needs of the commercial organization.
The ideal candidate will be a critical thinker and understand Neuroscience, Neuropsychology, neuropsychological assessment and measurement science.
**Specific responsibilities may include but are not limited to:**
**Clinical Planning**
+ Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
+ Contribute to business unit and global alignment of clinical strategy and clinical plans.
+ Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
**Clinical Research/Trial/ Execution and Support**
+ Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
+ Provide protocol oversight and input into informed consent documents.
+ Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
+ Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
+ Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
+ Participate in investigator identification and selection, in conjunction with clinical teams.
+ Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
+ Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
+ Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
+ Understand and actively address the scientific information needs of all investigators and personnel.
+ Review lIT proposals and publications, as requested by CRP or Director-Medical.
**Scientific Data Dissemination/Exchange**
+ Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
+ Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
+ Participate in reporting of clinical trial data in Clinical Trial Registry activities.
+ Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
+ Prepare or review scientific information in response to customer questions or media requests
+ Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
+ Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
+ Support the design of customer research as medical expert
+ Support medical information associates in preparation and review of medical letters and other medical information materials.
+ Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
+ Develop and maintain appropriate collaborations and relationships with relevant professional societies.
+ Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
+ Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
+ Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
**Regulatory Support Activities**
+ Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
+ Provide medical expertise to regulatory scientists.
+ Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
+ Participate in advisory committees.
+ Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
**Scientific I Technical Expertise and continued development**
+ Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
+ Responsible for the scientific training of the clinical study team.
+ Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
+ Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
+ Explore and take advantage of opportunities for extramural scientific experiences
+ Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
**General Responsibilities**
+ Actively set and meet individual professional development goals and contribute to the development of others.
+ Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
+ Actively participate in recruitment, diversity and retention efforts.
+ Collaborate proactively and productively with all alliance, business and vendor partners.
+ Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
+ Participate in committees, process improvement initiatives and task forces as requested by local/corporate management
+ Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
+ Model the leadership behaviors
+ Be an ambassador of both patients and the Lilly Brand
**Basic Requirements:**
+ Doctoral level Degree (Ph.D, Psy.D or equivalent) in Clinical Neuropsychology with 2+ years industry or academic experience beyond any postdoctoral positions.
+ Demonstrated experience in clinical and/or research settings in working with adults with neurological and/or psychiatric disorders
+ Clinical experience in conducting assessments and administering standardized scales within a clinical and/or research context.
+ Experience and agility in the conduct and interpretation of statistical and psychometric analyses
+ Evidence of scientific track record in publications, conference presentations
**Additional Information:**
+ Fluent in English, written and verbal communications
+ Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.
+ Position Location - Indianapolis, IN or Remote
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Research Support Officer Clinical - Clinical Nurse Manager 2 Cancer Research UCC
Posted today
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Research support officer clinical - clinical nurse manager 2 cancer research ucc
Posted today
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ABOUT UCC CTG: The UCC CTG is a new HRB funded collaborative team which aims to bring together a dedicated team of cancer specialists and research staff across the south of Ireland.
The UCC CTG is part of Cancer , a translational cancer research centre within the College of Medicine & Health at University College Cork.
The UCC CTG group includes 3 cancer trials units at Cork University Hospital ( ), University Hospital Waterford and Bons Secours Hospital Cork.
For more information about the group, check our website: or our Trials ABOUT ACADEMIC RESEARCH AT : The role will be hosted in Cancer and the Cancer Trials Cork Unit at CUH ( ) in the Breast Lung Gynaecology portfolio.
The CUH unit has been in operation for close to two decades, serving a geographically diverse population of 1.2 million in the South of Ireland.
This team has grown over the past few years and continued growth is projected for years to come.
The CNMII will work closely under the guidance of Professor Roisin Connolly /CNM3 /Nurse Management and team members.
As a summary, the role will include: Co-ordination of clinical and translational aspects of the project including direct interface with pathology department, scientific collaborators, external laboratories and data scientists etc.
Clinical responsibilities.
Working with pathology for slide cutting and storage, labelling etc Coordination of sample distribution to labs and payments/invoices for correlative studies.
Keeping accurate logs of the specimens and results, linking with Castor database (study database) where relevant Collection of clinical data from relevant databases when required for abstract preparation Supporting team meetings (minutes/agendas/follow up tasks) specific to the project Support other studies taking place in the Cancer Trials Cork unit at Cork University Hospital where deemed necessary and in keeping with funding requirements Engage cross-functionally with different stakeholders, knowledge sharing, and building relationships.
This role requires excellent communication and interpersonal skills, computer literacy, organization and an awareness of time management.
The MINA study - 'Microbiome Immunotherapy Neoadjuvant Assessment' - is a prospective observational study that aims to characterise and evaluate the bacterial population shown to be present in the immediate environment of breast tumours.
Previous work has shown that these bacteria can alter the effectiveness of some commonly used anti-cancer drugs, and so it is hoped that data from this study can support the development of new biomarkers that can measure how well some patients might respond to chemotherapy compared to others.
EXPERIENCE REQUIRED: Qualified Nurse (Mandatory RGN, BSc).
Oncology background or related experience would be a strong advantage.
Strong interest in gaining experience in this area will also be considered without previous experience in Oncology nursing.
WAYS TO GET IN TOUCH: You can confidentially email queries to or Or apply with your CV through Type the job ID into the keywords section and the role will come up.
Project Title: UCC Cancer Trials Group (Cancer / Cancer Trials ) Post Duration: 12 Months Salary: €61,463 - €77,666 p.a (CNM2 salary scale) (As required by public pay policy for the higher education sector, new appointments to a direct entry recruitment grade will generally be at the minimum (1st point) of the relevant scale.
For existing public servants, the restriction to the first point on scale may be varied where a person is appointed to the same or an analogous grade, role or position as their previous public service employment.) For an information package including further details of the post see Informal enquiries can be made in confidence to informal enquiries: to Prof.
Roisin Connolly or Applications must be submitted online via the University College Cork vacancy portal Queries relating to the online application process should be referred to quoting the job-title and project name.
Candidates should apply, in confidence, before 12 noon (Irish Local Time) on Friday 26th September 2025.
No late applications will be accepted.
Please note that an appointment to posts advertised will be dependent on University approval, together with the terms of the employment control framework for the higher education sector.
UCC is committed to creating and fully embracing an inclusive environment where diversity is celebrated.
As a University we strive to create a workplace that reflects the diversity of our student population where people from a wide variety of backgrounds learn from one another, share ideas, and work collaboratively.
UCC is committed to being an employer that recognises the value of diversity amongst its staff.
We encourage applicants to consult our policies at and initiatives at and we welcome applications from everyone, including those who are underrepresented in the protected characteristics set out in our Equal Opportunities & Diversity Policy.
UNIVERSITY COLLEGE CORK IS AN EQUAL OPPORTUNITIES EMPLOYER To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process, click the Apply button below to Login/Register.
Research Assistant - Clinical Therapies - Speech and Hearing
Posted today
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Research Assistant - Clinical Therapies Speech and Hearing
Posted today
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Research assistant - clinical therapies - speech and hearing
Posted today
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The aim of this programme of research is to ensure that interventions to support language and communication deliver maximum benefit for children with or at risk for developmental language disorder (D)LD.
To do this we aim to develop a set of internationally accepted reporting guidelines that will a) specify the intervention characteristics, participant characteristics and outcomes in children's oral language intervention studies b) reflect the perspectives of all relevant stakeholders c) enable translation of research into practice through comprehensive training d) maximise the potential for meta-analysis and international collaboration.
Our programme of research includes a multi-national core team of representatives from the key groups who will either use or be influenced by the final reporting guidance.
We will conduct reviews of the literature (which present typologies of intervention characteristics in (D)LD and related disorders); carry out focus groups; and use systematic consensus methods such as e-Delphi, nominal group technique, and consensus development conferences.
Through the development and adoption of standard intervention reporting criteria, we aim to reduce research waste, and to overcome barriers for practitioners, services and policymakers in applying intervention evidence to practice.
International consensus on intervention reporting, which incorporates key elements of relevance across stakeholders, would capitalise on the growth in intervention studies to enable new methodologies of data pooling, meta-analyses and cross-study comparisons.
Consequently, it would significantly accelerate progress in (D)LD intervention research and improve health; educational and economic outcomes for all those with or at risk for (D)LD (in Ireland and internationally) through more efficient and effective intervention approaches.
Further information can be found on the following website: Project Title: Maximising the benefits of intervention research to support language and communication in children.
Post Duration: 37 Months, Full -Time Post Salary: €33,291 - €43,372 p.a.
(IUA Salary Scale) For an information package including further details of the post see Informal enquiries can be made in confidence to Professor Pauline Frizelle, Department of Speech and Hearing Sciences Tel: + ; Email: Applications must be submitted online via the University College Cork vacancy portal Queries relating to the online application process should be referred to quoting the job-title and project name.
Candidates should apply, in confidence, before 12 noon (Irish Local Time) on Friday 3rd October 2025.
Interviews will be held online the week after the closing date for application No late applications will be accepted.
Please note that an appointment to posts advertised will be dependent on university approval, together with the terms of the employment control framework for the higher education sector.
UCC is committed to creating and fully embracing an inclusive environment where diversity is celebrated.
As a university we strive to create a workplace that reflects the diversity of our student population where people from a wide variety of backgrounds learn from one another, share ideas, and work collaboratively.
UCC is committed to being an employer that recognises the value of diversity amongst its staff.
We encourage applicants to consult our policies at and initiatives at and we welcome applications from everyone, including those who are underrepresented in the protected characteristics set out in our Equal Opportunities & Diversity Policy.
UNIVERSITY COLLEGE CORK IS AN EQUAL OPPORTUNITIES EMPLOYER To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process, click the Apply button below to Login/Register.
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About the latest Contract medical writer 12 month contract ireland Jobs in Ireland !
Research assistant - clinical therapies speech and hearing
Posted today
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The aim of this programme of research is to ensure that interventions to support language and communication deliver maximum benefit for children with or at risk for developmental language disorder (D)LD.
To do this we aim to develop a set of internationally accepted reporting guidelines that will a) specify the intervention characteristics, participant characteristics and outcomes in children's oral language intervention studies b) reflect the perspectives of all relevant stakeholders c) enable translation of research into practice through comprehensive training d) maximise the potential for meta-analysis and international collaboration.
Our programme of research includes a multi-national core team of representatives from the key groups who will either use or be influenced by the final reporting guidance.
We will conduct reviews of the literature (which present typologies of intervention characteristics in (D)LD and related disorders); carry out focus groups; and use systematic consensus methods such as e-Delphi, nominal group technique, and consensus development conferences.
Through the development and adoption of standard intervention reporting criteria, we aim to reduce research waste, and to overcome barriers for practitioners, services and policymakers in applying intervention evidence to practice.
International consensus on intervention reporting, which incorporates key elements of relevance across stakeholders, would capitalise on the growth in intervention studies to enable new methodologies of data pooling, meta-analyses and cross-study comparisons.
Consequently, it would significantly accelerate progress in (D)LD intervention research and improve health; educational and economic outcomes for all those with or at risk for (D)LD (in Ireland and internationally) through more efficient and effective intervention approaches.
Further information can be found on the following website: Project Title: Maximising the benefits of intervention research to support language and communication in children.
Post Duration: 33 Months, Full -Time Post Salary: €33,291 - €43,372 p.a.
(IUA Salary Scale) For an information package including further details of the post see Informal enquiries can be made in confidence to Professor Pauline Frizelle, Department of Speech and Hearing Sciences Tel: + ; Email: Applications must be submitted online via the University College Cork vacancy portal Queries relating to the online application process should be referred to quoting the job-title and project name.
Candidates should apply, in confidence, before 12 noon (Irish Local Time) on Friday 26th of September 2025.
Interviews will be held online the week after the closing date for application No late applications will be accepted.
Please note that an appointment to posts advertised will be dependent on university approval, together with the terms of the employment control framework for the higher education sector.
UCC is committed to creating and fully embracing an inclusive environment where diversity is celebrated.
As a university we strive to create a workplace that reflects the diversity of our student population where people from a wide variety of backgrounds learn from one another, share ideas, and work collaboratively.
UCC is committed to being an employer that recognises the value of diversity amongst its staff.
We encourage applicants to consult our policies at and initiatives at and we welcome applications from everyone, including those who are underrepresented in the protected characteristics set out in our Equal Opportunities & Diversity Policy.
UNIVERSITY COLLEGE CORK IS AN EQUAL OPPORTUNITIES EMPLOYER To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process, click the Apply button below to Login/Register.
Principal Medical Writer EMEA (Client-embedded)

Posted 4 days ago
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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.
Consultant/Medical Writer - Global Value Dossiers
Posted 1 day ago
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