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Associate Director of Medical Writing

Trenton Metro Area, NJ

Post Date: 02/23/2018 Job ID: JN -022018-21010 Job Type: Clinical
  • POSITION SUMMARY
    The Associate Director, Medical Writing (Safety and Disclosure) works in partnership with the leadership of the Medical Writing Department and is the primary overseer and performer for the medical writing activities that ensure regulatory requirements for ongoing safety reporting and results disclosure are met, across all clinical programs.

  • ROLES AND RESPONSIBILITIES
    Responsibilities include but are not limited to:
  • Serving as the Safety and Disclosure Medical Writing Lead
  • Ensuring that documents are appropriate for their target audience while also meeting all regulatory requirements
  • Managing, leading, and/or assisting more junior writers and other medical writing-related staff (including contract or CRO staff)
  • Leading safety and disclosure medical writing vendor selection, contracting, and management
  • Building and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the medical writing community)
  • Performing document-specific tasks such as:
    • (a) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells
    • (b) ensuring editorial review of documents (grammar, punctuation, and formatting)
    • (c) ensuring quality-checking of documents (including for submission-ready formatting)
  • Ensuring compliance with templates and standard operating procedures (SOPs) and applying the principle of continuous improvement to all in-house and contracted medical writing procedures for safety and disclosure
  • Contributing to cross-functional team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
  • Providing training and guidance on safety and disclosure medical writing best practices
  • Participating in projection of annual budget and resource needs for safety and disclosure medical writing

  • REQUIREMENTS
  • The ideal candidate will possess a graduate level education
  • A minimum of 4 to 8 years experience with related work within a pharmaceutical company or CRO; all clinical or clinical research experience will be considered

  • EXPERIENCE AND SKILLS
  • Experience across most types of regulatory medical writing deliverables, with specific experience in regulatory documents to address safety reporting requirements (eg, IBs, DSURS, PBRERs) and results disclosure (eg, CT.gov and EudraCT results reporting)
  • Experience with submissions-level safety documents/elements (Integrated Summary of Safety, Summary of Clinical Safety)

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