Associate Director, Medical Writing & Regulatory Submissions

Taylor Strategy Partners; Boston (MA); On-site; USD 130,000 - 190,000; Full time

Job summary

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory and clinical documentation. The role reports to the VP of Regulatory Affairs and supports submissions across the US, UK, and EU, coordinating with vendors and cross-functional teams.

You will author, review, and coordinate high-quality documents for interactions with FDA, EMA, and MHRA, ensuring adherence to ICH guidelines and current industry standards.

Qualifications

• 8+ years medical writing in biotech/pharma/CRO environments.
• Experience authoring regulatory submissions and clinical documents for FDA/EMA/MHRA.
• Strong knowledge of ICH, GCP, global regulatory requirements.

Responsibilities

• Lead development of regulatory documents for FDA, EMA, MHRA and others.
• Author/oversee Clinical Overview and Clinical Summary documents, orphan drug applications, pediatric plans, briefing documents, and responses to health authority questions.
• Partner with Regulatory Affairs for scientific advice meetings and IND/CTA interactions.
• Ensure documents adhere to ICH guidelines and regulatory requirements.
• Support preparation of documents for CTAs, regulatory amendments, annual reports, and MAAs.

Skills

Regulatory writing leadership

Clinical/regulatory documents

ICH guidelines

Independent document leadership

Education

MS/PhD/ PharmD in life sciences

Job description

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory and clinical documentation. The role reports to the VP of Regulatory Affairs and supports submissions across the US, UK, and EU, coordinating with vendors and cross-functional teams.

You will author, review, and coordinate high-quality documents for interactions with FDA, EMA, and MHRA, ensuring adherence to ICH guidelines and current industry standards.