Senior Medical Writer – Vaccine

Sanofi

Senior Medical Writer driving clinical document creation and coordination for vaccine development at Sanofi. Collaborating within clinical teams to ensure compliance with standards and regulatory requirements.

Posted 7/13/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesSenior💰 $122,250 - $176,583 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical and regulatory medical writing, including the creation and coordination of clinical documents, protocols, and reports. Proficient in project management and mentoring within a pharmaceutical or clinical research environment.

Highest-signal resume keywords

Clinical And Regulatory Medical WritingProject ManagementFluent English CommunicationTechnical Writing SkillsDocument Quality Control

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study PerformanceClinical MethodologyBasic StatisticsDocument CoordinationCTD Clinical SummariesInformed Consent FormsInvestigator BrochuresClinical Study ReportsSOP DevelopmentPeer Review

Soft Skills

Interpersonal SkillsTime Management

Tools & Technologies

Word ProcessingElectronic Document TemplatesExcelOutlookEndNoteRead CubePlease Review

Industry Keywords

Life SciencesPharmaceutical CompanyClinical Research OrganizationRegulatory Environment

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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).

Benefits

Comp & perks

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.