Job title: Senior Medical Writer - Vaccine
Location: Swiftwater, PA
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 YouBasic 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).
The salary range for this position is:
$122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
