Senior Medical Writer - Vaccine

Job title:Senior Medical Writer - Vaccine

Location:Swiftwater, PA

About the Job

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.

Main 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.

About You

Basic Qualifications:

• 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).

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.