Clinical Regulatory Writing Associate Director

The Fountain Group is currently seeking a Clinical Regulatory Writing Associate Director for a prominent client of ours. This position is located in Boston, MA. Details for the position are as follows:

• Pay: $75-85/hr.
• 100% Onsite in Boston, MA 02210
• 12-month assignment with possibility for extension or conversion based on performance and budget.
  
  

Responsibilities:

• Manage clinical regulatory writing activities for complex drug development programs and submissions.
• Author and review clinical-regulatory documents including CSRs, protocols, investigator brochures, and submission materials in compliance with global regulatory standards.
• Lead submission communication strategies and translate complex clinical data into clear, concise regulatory messaging.
• Collaborate cross-functionally with Clinical, Regulatory, Biostatistics, and Medical Affairs teams to support successful submissions and approvals.
• Manage internal and external medical writing teams to ensure high-quality deliverables are completed on time.
• Drive communication best practices, operational excellence, and mentoring of junior regulatory writing staff.
  
  

Qualifications:

• Master’s degree required; PhD preferred in a scientific or life sciences discipline.
• 4-5 years of experience in Medical Writing, Regulatory Writing, or Clinical Writing within the pharmaceutical, biotech, CRO, or consulting industry.
• Strong experience leading and advising communication and regulatory writing projects.
• Understanding of the drug development process from early development through product launch and lifecycle management.
• Knowledge of clinical and regulatory communication strategies and documentation requirements across the product lifecycle.
  
  

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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