Senior Medical Writer - Vaccine

Sanofi•Swiftwater, PA

6d•Remote

About The Position

The Senior Medical Writer is a member of the Clinical Team. He/she is responsible for the production of key documents related to Clinical Department and Global Medical Affairs activities (e.g., concept documents, protocol, CSR, IBs, Informed Consent Forms, expert reports/integrated summaries, CTD Modules 2 and 5, etc.) in line with the Company as well as external standards, e.g., regulatory requirements or guidelines. The Medical Writing platform is within Clinical Programs. The Medical Writer reports to the Local Head of Medical Writing for mentoring, appraisal and training. He/she may be the representative of his/her function in one or several clinical teams according to the number of projects he/she has to manage. In this case, he/she is accountable to the Clinical Team Leader for all project issues. The Medical Writer is a member of one or more clinical teams according to the projects he/she has been assigned. His/her role is to be the referent for his/her function within the team. He/she will be responsible for coordinating the writing of major documents to conduct trials of the projects. He/she has to work in close collaboration with other functions/members of the clinical team to achieve the correct writing of documents. Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Requirements

Advanced degree in Life Sciences or related field of study.
3 or + years of clinical and regulatory medical writing experience within a pharmaceutical company or clinical research organization (CRO).
Fluent English communication skills, verbal and written.
Professional background documenting an excellent understanding of and experience in clinical development including clinical study performance/methodology/ basic statistics and/or the regulatory environment.
Demonstrated strong interpersonal, time management and technical writing skills.
Excellent word-processing skills and experience with electronic document templates are required and other relevant applications (eg, Excel, Outlook, EndNote, Read Cube, Please Review).

Responsibilities

Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs
Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs.
Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department
Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer)
Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF)
Contributes to the development of document templates and relevant SOPs.
Represents the platform on committees and working groups within Clinical as requested
Provides mentoring support to less experienced colleagues and new Company staff members if needed
Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing
Is in charge of supervising subcontracted medical writing activities if needed.
May contribute to the updates of templates, SOPs, and other guides for Medical Writing.