Associate Director, Medical Writing

San Mateo Metro Area, CA

Job Type: Clinical Job Number: JN -082023-31893 Region: San Mateo Metro Area

Job Description

Our biotech client is recruiting for a Associate Director, Medical Writing to join their growing team.

  • Oversee the medical writing processes, procedures, strategies, document generation and maintenance
  • Lead development of clinical study documents to meet global regulatory standards
  • Proactively participate in budget setting, forecasting, and other aspects of financial management of clinical studies
  • Collaboratively work with Clinical Operations to embed quality and GCP compliance within day-to-day activities
  • Identify risks and implement mitigation strategies
  • Advanced degree (Ph.D. or PharmD) preferred
  • Over 10 years of medical writing experience in the clinical research or biotechnology industry
  • Experience as lead writer for key documents included in major US and/or international regulatory submissions required
  • Demonstrate an in-depth knowledge of clinical development and the regulatory environment
  • Ability to work effectively under a fast-paced and changing environment

Salary Range:

  • $190,000 to $205,000 (Dependent on Experience)

R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.

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