Associate Director, Medical Writing: Regulatory Submissions

TSP, a Syneos Health company; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

TSP, a Syneos Health company, is seeking an Associate Director, Medical Writing to lead regulatory and clinical writing activities across the US, UK, and EU. The role will author, review, and coordinate high-quality documents for conversations with FDA, EMA, and MHRA, while coordinating with cross-functional teams and external vendors.

The ideal candidate will have 8+ years in medical writing within biotech/pharma/CRO, an advanced life sciences degree, and a proven ability to independently

Qualifications

• Advanced degree (MS, PhD, PharmD, or equivalent) in a life sciences discipline.
• 8+ years of medical writing experience within biotech, pharma, or CRO environments.
• Demonstrated experience authoring regulatory submissions and clinical documents for FDA/EMA/MHRA.
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements.

Responsibilities

• Lead development of regulatory documents supporting submissions to FDA, EMA, MHRA, and other global agencies.
• Author or oversee Clinical Overview and Clinical Summary documents, orphan drug applications, pediatric plans, briefing documents, and responses to health authority questions.
• Partner with Regulatory Affairs to support scientific advice meetings, pre-IND/IND meetings, and interactions with European and UK regulatory authorities.
• Ensure regulatory documents adhere to ICH guidelines and regional regulatory requirements.
• Support preparation of documents for CTAs, regulatory amendments, annual reports, and MAAs.

Skills

Medical writing

Regulatory writing

Regulatory submissions

ICH guidelines

GCP

Project leadership

Education

MS/PhD/PharmD

Job description

TSP, a Syneos Health company, is seeking an Associate Director, Medical Writing to lead regulatory and clinical writing activities across the US, UK, and EU. The role will author, review, and coordinate high-quality documents for conversations with FDA, EMA, and MHRA, while coordinating with cross-functional teams and external vendors.

The ideal candidate will have 8+ years in medical writing within biotech/pharma/CRO, an advanced life sciences degree, and a proven ability to independently