Associate Director, Medical Writing & Regulatory

TSP, a Syneos Health company; Philadelphia (Philadelphia County); On-site; USD 140,000 - 210,000; Full time

Job summary

TSP, a Syneos Health company, is seeking an Associate Director, Medical Writing to lead strategic and operational support for regulatory submissions and clinical development activities across the United States, United Kingdom, and EU. The role reports to the VP of Regulatory Affairs and serves as the lead medical writer, coordinating high-quality documents for FDA, EMA, and MHRA.

Ideal candidates will have 8+ years of medical writing experience in biotech/pharma/CRO, an advanced life sciences

Qualifications

• Advanced degree in a life sciences discipline (MS/PhD/PharmD or equivalent) required.
• 8+ years of medical writing experience in biotech, pharmaceutical, or CRO environments.
• Proven ability to author/regulatory submissions for FDA/EMA/MHRA and related health authorities.

Responsibilities

• Lead development of regulatory documents for FDA/EMA/MHRA submissions.
• Author or oversee Clinical Overview, Clinical Summary, orphan drug applications, pediatric plans, briefing documents, and responses to health authority questions.
• Collaborate with Regulatory Affairs for meetings with European/UK authorities and cross-functional partners.
• Ensure documents comply with ICH guidelines, regional regulatory requirements, and current industry standards.
• Prepare documents for CTAs, regulatory amendments, annual reports, and MAAs as needed.

Skills

Regulatory submissions

Medical writing

ICH/GCP knowledge

Leadership

Cross-functional collaboration

Education

Advanced life sciences degree

Job description

TSP, a Syneos Health company, is seeking an Associate Director, Medical Writing to lead strategic and operational support for regulatory submissions and clinical development activities across the United States, United Kingdom, and EU. The role reports to the VP of Regulatory Affairs and serves as the lead medical writer, coordinating high-quality documents for FDA, EMA, and MHRA.

Ideal candidates will have 8+ years of medical writing experience in biotech/pharma/CRO, an advanced life sciences