Biotech/Pharmaceutical

Senior Medical Writer – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
Senior Level Medical Writer (AD level)


Contract to Hire

Job Description:  Will write and edit clinical regulatory documents, including submission summaries and other complex documents, provides a significant level of oversight and expert guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. The Director offers clear leadership and extensive accountability, strategic vision, and planning for clinical regulatory documents.

Essential Duties & Responsibilities:

  • Primarily works on the assigned therapeutic area (TA)/functional level. In some cases, will have oversight and be responsible for Medical Writing deliverables for one or more compounds outside the assigned TA
  • Oversees/mentors for all document types
  • May write and edit clinical regulatory documents (all types)
  • Ensures that documents include the proper context and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
  • Leads/recommends the preparation/revision of document templates
  • Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
  • Responsible for tracking/providing metrics and established key performance indicators

Position Requirements:

  • PhD or PharmD in life sciences (or other related field) or Master’s degree in life sciences (or other related field)
  • PhD or Pharm D with a minimum of 9 years of experience or Master degree with minimum of 11 years of experience

 

Tagged as: Senior Medical Writer - Remote