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Associate Director of Medical Writing & Regulatory Submissions

Location: Los Angeles Metro Area, California Salary: competitive
Sector: Regulatory Affairs Type: Permanent

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.