• 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.