R&D Partners
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Associate Director, Medical Writing
Job Description
Our biotech client is recruiting for a Associate Director, Medical Writing to join their growing team.
Summary:
Summary:
- 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.