Senior Medical Writer - Vaccine

About the role

The Senior Medical Writer is a member of the Clinical Team responsible for producing key documents related to Clinical Department and Global Medical Affairs activities. These include concept documents, protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms, expert reports/integrated summaries, and CTD Modules 2 and 5, adhering to company and external regulatory standards. The role involves close collaboration with clinical teams and other functions to ensure accurate and timely document production. The Medical Writer reports to the Local Head of Medical Writing for mentoring and appraisal and may represent the function in one or more clinical teams, accountable to the Clinical Team Leader for project-related issues.

Join a team protecting half a billion lives annually through next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance global prevention and shape the future of immunization.

Responsibilities

• Create, write, and coordinate concept documents, protocols, Informed Consent Forms, and Clinical Study Reports according to Sanofi Pasteur document standards, tools, and SOPs.
• Create, coordinate, compile, and edit Investigator Brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) in line with Sanofi Pasteur standards.
• Write and coordinate CTD clinical summaries and overviews, manage medical writing CTD activities (including interaction with Regulatory Affairs and other functions), and provide supportive activities within the Medical Writing department.
• Serve as a member of the clinical team, accountable to the Clinical Team Leader for project issues, acting as the referent medical writer.
• Participate in peer-review and quality control cross-checks of documents produced by the Medical Writing platform and review documents from other departments (e.g., SAP, CRF).
• Contribute to the development of document templates and relevant SOPs, and represent the platform on committees and working groups within Clinical as requested.
• Provide mentoring support to less experienced colleagues and new staff members.
• Manage medical writing deliverables for trials or projects, including negotiating timelines and escalating issues to the clinical team and Local Head of Medical Writing.
• Supervise subcontracted medical writing activities if needed.
• Contribute to updates of templates, SOPs, and other guides for Medical Writing.

Requirements

• Advanced degree in Life Sciences or a related field.
• 3+ years of clinical and regulatory medical writing experience within a pharmaceutical company or Clinical Research Organization (CRO).
• Fluent English communication skills, both verbal and written.
• Professional background demonstrating an excellent understanding of clinical development, including clinical study performance, methodology, basic statistics, and/or the regulatory environment.
• Strong interpersonal, time management, and technical writing skills.
• Proficiency in word-processing tools and experience with electronic document templates and relevant applications (e.g., Excel, Outlook, EndNote, ReadCube, Please Review).

Benefits

• Opportunities for career growth through promotions, lateral moves, or international assignments.
• Comprehensive rewards package recognizing contributions and amplifying impact.
• Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms.
• Contribute to protecting half a billion people annually through global vaccination efforts.
• Access to mentoring, international mobility programs, and career development opportunities across four continents.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.