Remote work okay
Responsibilities
- Author, co-author, critically edit, and format regulatory documents including NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissions
- Manage medical writing contracted with independent consultants, CROs, and other communication vendors
Manage overall medical writing timelines and resources across project teams (including internal and external resources)
Serve as the functional area lead on project teams and advise such teams on content, format, and style-guide requirements for documents
Lead the development of medical writing processes, SOPs, work instructions, and document quality control
Participate in the development of publication plans
Manage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expands
Knowledge, Skills, and abilities required
- Previous experience preparing clinical Regulatory documents
- Demonstrated success managing medical writers
Sthree US is acting as an Employment Agency in relation to this vacancy.
