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Medical Writer

  • Location: Parsippany-Troy Hills Township
  • Salary: US$80000 - US$115000 per annum + + Bonus per year
  • Job Type:Permanent

Posted 28 days ago

Role Responsibilities

  • Creates documents pertaining to clinical studies and regulatory submission/interactions, including (but not limited to) protocols, IB, ICF, GIP, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
  • Produces documents in conjunction with vendors. Reviews documents produced by vendors and helps evaluate vendor performance.
  • Follows up with other functional groups for materials needed for document completion.
  • Tracks writing progress, and ensures adherence to regulatory guidelines and department document standards (SOPs etc.).
  • Ensures maintenance of document standardization through use of model documents/templates.
  • Applies comprehensive knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.
  • Other responsibilities assigned as needed.




Qualifications

  • Advanced degree (MS/MA/PhD) is preferred.
  • A minimum of 3 years in Medical Writing with experience of IND and marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred.
  • Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
  • Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
  • Adapts to change as needed.
  • Knowledge of using publicly available databases (eg, PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and citing such information appropriately.
  • Language skills. High fluency in spoken and written English. Mandarin speaking is a plus.



***Must be onsite one day per week!***

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