Senior Medical Writing Project Lead M - W H/F Servier

Role Summary
The Senior Medical Writing Program Lead will be responsible for the creation of English-language medical writing deliverables at Servier, ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2) manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, 3) mentor junior writing staff, 4) manage external vendor writer activities and 5) be the Medical Writing Program Lead for a particular drug development franchise within Servier.

Primary Responsibilities
- Coordinate medical writing activities and deliverables at the asset program level
- Work cross-functionally to write clinical and regulatory documents in support of regulatory submissions to accurately and consistently present key clinical messages in accordance with program goals, regulatory requirements, standards, and guidelines
- Serve as the main medical writing contact on study teams, coordinating the efforts of cross-functional teams for document development
- Detailed scheduling and management of cross-functional team deliverables impacting document delivery at the program level
- Mentor and manage the work of more junior writers
- Manage the work and deliverables of contract/vendor writers

Education and Required Skills
- Bachelor's degree in a relevant scientific/clinical/regulatory field required (graduate degree preferred)
- 7+ years of medical writing experience (dependent upon graduate degree)
- History of leading major submissions to health authorities, including INDs and MAAs
- History of authoring regulatory strategic documents in support of health authority interactions
- Excellent verbal and written communication skills
- Exceptional organizational skills and attention to detail
- Project management skills and proficiency with MS Project
- Proficiency with relevant software for document authoring, referencing and approval workflows
- Flexibility and agility with changing priorities and timelines

Travel and Location
- Some domestic and international travel will be required
- Located at Servier headquarters, Saclay, France

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