Senior Medical Writing Lead – Regulatory Submissions

Taylor Strategy Partners; Atlanta (GA); On-site; USD 180,000 - 230,000; Full time

Job summary

Taylor Strategy Partners seeks an Associate Director, Medical Writing to lead regulatory and clinical writing for US, UK, and EU submissions. You will author, review, and coordinate key documents and support interactions with health authorities.

You will report to the VP of Regulatory Affairs, drive cross-functional collaboration, guide vendors, ensure ICH/GCP compliance, and independently manage complex document programs in a fast-paced biotech setting.

Qualifications

• Advanced degree in a life sciences discipline.
• 8+ years of medical writing in biotech/pharma/CRO.
• Experience authoring regulatory submissions for FDA/EMA/MHRA.
• Strong knowledge of ICH guidelines, GCP, and global regulatory requirements.
• Ability to independently lead complex document projects.

Responsibilities

• Lead development of regulatory documents for FDA/EMA/MHRA submissions.
• Author or oversee Clinical Overview, Clinical Summary, orphan drug apps, pediatric plans, and responses to questions.
• Collaborate with Regulatory Affairs for meetings with European/UK authorities.
• Ensure documents comply with ICH guidelines and regional requirements.
• Support CTAs, regulatory amendments, annual reports, and MAAs in relevant regions.

Skills

Regulatory writing

Leadership of documents

Cross-functional collaboration

ICH/GCP knowledge

Strategic thinking

Education

MS/PhD/PharmD or equivalent in life sciences

Job description

Taylor Strategy Partners seeks an Associate Director, Medical Writing to lead regulatory and clinical writing for US, UK, and EU submissions. You will author, review, and coordinate key documents and support interactions with health authorities.

You will report to the VP of Regulatory Affairs, drive cross-functional collaboration, guide vendors, ensure ICH/GCP compliance, and independently manage complex document programs in a fast-paced biotech setting.