Manager, Medical Writing

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Full-time Employment / Unlimited

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About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision.

Role Summary

The Manager, Medical Writing will be an active contributor/lead author of regulatory and scientific documentation, will manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, and will manage external vendor writers’ deliverables. Document examples include but will not be limited to clinical protocols, clinical study reports, investigator’s brochures, and clinical sections of investigational new drug applications and marketing applications.

Strategic regulatory documents such as agency responses and briefing packages will also be authored/managed. The manager 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.

Documents include, but are not limited to, clinical study reports, protocols, summaries/overviews, investigator’s brochures, clinical sections of investigational new drug applications, contributions to agency response documents, and other global regulatory submission materials.

Primary Responsibilities

• For assigned clinical studies, serve as the main medical writing contact on study teams ensuring accuracy, consistency, and regulatory compliance in a variety of clinical regulatory documents as outlined above
• With limited supervision, author, edit, and manage project deliverables with minimal supervision, including timeline development, project management, and active participation on cross-functional project teams
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents meeting all applicable regulations, standards, and guidelines, including ICH
• Prepare responses to questions from regulatory agencies; write briefing packages, other strategic regulatory documents such as accelerated review applications, and assist with materials for presentations at agency meetings and advisory committee meetings as needed
• Manage the work and deliverables of contract/vendor writers, as needed
• Promote continuous improvement by influencing cross-functional practices to enhance quality, compliance, and efficiency
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs

Education and Required Skills

• Bachelor’s degree in relevant scientific/clinical/regulatory field required with a minimum of 5 years of Medical Writing experience;
  Advanced degree in a relevant scientific/clinical/regulatory field preferred
• Excellent verbal and written communication skills, with the ability to collaborate effectively in a global team environment and build strong cross-functional relationships
• Strong project management skills with the ability to manage multiple projects with competing priorities; proficiency with MS Project preferred
• Exceptional organizational skills, attention to detail, and ability to work independently with minimal supervision
• Ability to work on a study team and complete deliverables with minimal supervision
• Ability to adapt to changing priorities and exercise sound judgment in decision-making
• Technical proficiency with authoring software such as MS Word; experience with reference managers/abbreviation managers/QC tool is desirable
• Experience partnering with CROs to ensure adherence to best practices and evaluating outsourcing strategies
• Global regulatory submission experience
• Familiarity with GCP and ICH guidelines
• Experience with authoring/management of clinical and non-clinical documents for drug development

Travel and Location

• Some…