Associate Director, Medical Writing in Basking Ridge at Daiichi Sankyo

Date Posted: 1/21/2023

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Basking Ridge
  • Experience:
    Not Specified
  • Date Posted:
    1/21/2023
  • Job ID:
    R1336

Job Description

Summary


The primary responsibilities of this position are to write, with minimal supervision of the lead author (Director, Medical Writing) complex documents including BLA/MAA submission documents (eg, Summary of Clinical Safety) and responses to HA requests for information. This position will contribute to strategy development for document authoring, and contribute strategically and scientifically at the study team level. The Associate Director, Medical Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).

Responsibilities

  • Write critical, complex clinical documents (eg, pivotal Phase 3 study protocols and reports, NDA/BLA/MAA submission documents) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents; support the lead author (Director, Medical Writing) in the search of scientific literature to place study results in context with other relevant data
  • Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
  • Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
  • Participate in initiatives with Medical Writing Group in Japan and the EU to identify Medical Writing process improvement opportunities, potential collaborations and drive changes as needed etc.
  • Aid Director, Medical Writing in determining resource needs, proactively identify issues and solutions, and contribute to timelines and processes

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.


Experience Qualifications

  • 4 or More Years of experience as a medical writer with a graduate degree in a relevant science field preferred or
  • 7 or More Years of experience as a medical writer with a Bachelor's degree in a relevant science field preferred
  • Regulatory Medical writing experience required
  • Submission document writing experience preferred

Travel

Ability to travel up to 5% In-house/remote office position that may require domestic/global travel.