32 Emplois pour Médical - France

**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.
Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, reviews documents for the team and provides training and guidance to junior team members. Provides advice on document development strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Acts as backup program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Key Responsibilities:
- Researches, writes, and edits clinical study reports and study protocols, and
summarizes data from clinical studies.
- May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document
preparation, the use of software for document development, document types,
regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned
documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various clientspecific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects.
- May serve as backup program manager. Identifies and resolves out-of-scope
activities. Duties could include developing timelines, budgets, forecasts and
contract modifications, and assisting business development with client
presentations and proposal text review, and attending bid defense meetings and capabilities presentations.
- Represents the department at project launch meetings, review meetings, and
project team meetings.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Experience in managing and directing complex medical writing projects required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Knowledge, Skills, and Abilities:
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Excellent project management skills
- Advanced interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Excellent judgment; high degree of independence in decision making and problem solving
- Ability to mentor and lead 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.

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 Senior Medical Writer is responsible for providing clinical EUHTA document support to the JCA core team, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process. The Senior Medical Writer will help to establish the new capability (eg medical writing) for IMAP.
Provides HTA medical writing expertise for multiple compounds and/or projects, expertise in HTA, oncology is a plus within a therapeutic area.
Interfaces with JCA core and extended teams (e.g., HTA Strategy, Access, DSS HTA Stats, VAC, HEOR S, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/delivery of information and review of clinical EUHTA submissions.
The Senior Medical Writer is responsible for providing clinical EUHTA document support to the JCA core team, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process. The Senior Medical Writer will help to establish the new capability (eg medical writing) for IMAP.
Provides HTA medical writing expertise for multiple compounds and/or projects, expertise in HTA, oncology is a plus within a therapeutic area.
Interfaces with JCA core and extended teams (e.g., HTA Strategy, Access, DSS HTA Stats, VAC, HEOR S, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/delivery of information and review of clinical EUHTA submissions.
+ Demonstrated capability to write all HTA dossier document types in remit, regardless of complexity.
+ Independently writes highly complex clinical JCA submissions documents and dossier components including but not limited to Sections, Appendices of JCA dossier, Health Authorities (HA) responses, and summary documents, support development of PICO, MAAP and Post Hoc analysis requests.
+ Serves as a lead on JCA clinical and regulatory dossier documents and documents such as those associated with agency interactions.
+ Functions with a high degree of autonomy on draft materials, but relies on review of subject matter experts. Develops knowledge and contributes to understanding of submission strategy development.
+ Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects.
+ Manages and supervises Vendor Medical Writing team.
+ Arranges and conducts review meetings with the team.
+ Produces and maintains clinical documents focusing on quality and compliance and ensures delivery within project timelines. Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives.
+ Helps to establish medical writing capability within IMAP through the support of process and governance development.
+ Develops knowledge of JCA and international regulations, requirements, and guidelines pertaining to the preparation of JCA documentation. Guidance associated with preparation of JCA documentation.
+ Participates in execution of tactical process improvements.
+ Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
Qualifications
+ A minimum of 6 + years of bio-pharmaceutical industry experience in global pharma, biotech, life science, HTA agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
+ Extensive experience in writing HTA dossiers, eg AMNOG, HAS, NICE, CDA dossier preferred.
+ Bachelor's Degree or higher in a scientific discipline.
+ Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
+ Proficient in assimilating and analyzing complex data.
+ Advanced understanding of HTA dossiers and HTA requirements, clinical research, study designs, biostatistics. Good understanding of regulatory requirements, and medical terminology cross functional teams and multiple contributors.
+ Excellent English writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders.
+ Ability to collaborate with cross-functional teams.
+ Strong organizational, time management, and problem-solving skills.
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.
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