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Director of Medical Writing

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SciPro

2021-12-04 07:30:03

Job location Dayton, New Jersey, United States

Job type: fulltime

Job industry: HR / Recruitment

Job description

  • Provide leadership and establish strategies for document authoring to projects/study teams at the organization level; Plan and coordinate medical writing activities in collaboration with stakeholders within and across regions. Critically review documents produced by writers for scientific content and alignment with company position, clarity, accuracy, and consistency
  • Contribute strategically and scientifically at the project and/or study team level; Contribute to formation of key messages in consultation with functional area experts; Advise project and study teams regarding regulatory requirements and ICH guidance for clinical documents
  • Determine resource needs based on workload and project priorities and communicate in a timely fashion; Develop contingency plans to address the business needs based on current therapeutic area projects and anticipation of future therapeutic area projects
  • Write critical, complex clinical documents (e.g., pivotal Phase 3 protocols and reports, BLA/MAA submission documents) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents
  • Represent Medical Writing on Global Medical Writing Committees; Liaise with International Medical Writing Group to identify Medical Writing process improvement opportunities, potential collaborations and drive changes as needed etc.
  • Sourcing Strategy and Management of Outsourced Medical Writing; Provide strategic input on plans for outsourcing medical writing and collaborate with Outsourcing and Legal on CRO/niche CROs selection
  • Leads BLA /NDA/MAA submission writing strategy
  • Mentor Medical Writers, assess performance, productivity, and development

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