Senior Medical Writer – Vaccine

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Responsible for the creation, writing, and coordination of concept documents, protocols, informed consent forms, and clinical study reports in accordance with Sanofi Pasteur's document standards, tools, and SOPs.

• Tasked with the creation, coordination, compilation, and editing of investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) following Sanofi Pasteur's standards, tools, and SOPs.

• Accountable for the creation, writing, and coordination of CTD clinical summaries and overviews in alignment with Sanofi Pasteur document standards, as well as coordinating medical writing CTD activities (interacting with RA and other involved functions) and providing CTD support within the medical writing department.

• Participates as a member of the clinical team, accountable to the Clinical Team Leader for all project-related issues (serving as the referent medical writer).

• Engaged in peer-review and QC cross-check of documents generated by the Medical Writing platform and in reviewing documents produced by other departments (such as SAP and CRF).

• Assists in the development of document templates and relevant SOPs.

• Represents the platform on committees and working groups within Clinical upon request.

• Offers mentoring support to less experienced colleagues and new Company staff members as required.

• Manages project timelines and deliverables for medical writing within a trial or project, including negotiating deadlines and identifying and escalating issues to both the clinical team and the local Head of Medical Writing.

• Oversees subcontracted medical writing activities as necessary and may contribute to the updates of templates, SOPs, and other Medical Writing guides.

⛳️ Requirements

• Advanced degree in Life Sciences or a related field of study.

• A minimum of 3 years of clinical and regulatory medical writing experience within a pharmaceutical company or clinical research organization (CRO).

• Proficient in English communication skills, both verbal and written.

• Professional background demonstrating a solid understanding of and experience in clinical development, including clinical study performance/methodology/basic statistics and/or the regulatory environment.

• Proven strong interpersonal, time management, and technical writing abilities.

• Excellent word-processing skills along with experience using electronic document templates and other relevant applications (e.g., Excel, Outlook, EndNote, Read Cube, Please Review).

🏝️ Benefits

• Enjoy a thoughtfully designed rewards package that acknowledges your contributions and enhances your impact.

• Take care of yourself and your family with a comprehensive range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.