Senior Medical Writing Director, Regulatory Submissions

Taylor Strategy Partners; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Job summary

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory and clinical document development across the US, UK, and EU. The role reports to the VP of Regulatory Affairs and requires hands-on leadership for strategic and operational writing, review, and coordination with cross-functional teams and external vendors.

Ideal candidates bring 8+ years in biotech/pharma medical writing, with proven ability to author regulatory submissions for FDA/EMA/MHRA and to drive

Qualifications

• Advanced degree in life sciences (MS, PhD, PharmD) or equivalent.
• 8+ years medical writing experience in biotech, pharma or CRO.
• Experience authoring regulatory submissions for FDA/EMA/MHRA.

Responsibilities

• Lead development of regulatory documents for FDA, EMA, MHRA and other agencies.
• Author or oversee Clinical Overview and Clinical Summary documents, orphan drug apps, pediatric plans, briefing documents and responses to health authority questions.
• Partner with Regulatory Affairs for meetings and interactions with European and UK regulators.
• Ensure documents adhere to ICH guidelines and regional regulatory requirements.
• Support documents for CTAs, regulatory amendments, annual reports and MAAs.

Skills

Regulatory submissions

ICH/GCP knowledge

Vendor management

Education

MS/PhD/PharmD in life sciences

Job description

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory and clinical document development across the US, UK, and EU. The role reports to the VP of Regulatory Affairs and requires hands-on leadership for strategic and operational writing, review, and coordination with cross-functional teams and external vendors.

Ideal candidates bring 8+ years in biotech/pharma medical writing, with proven ability to author regulatory submissions for FDA/EMA/MHRA and to drive