Senior Medical Writing Lead, Regulatory Submissions

Taylor Strategy Partners; Raleigh (NC); Presencial; USD 140.000 - 210.000; Jornada completa

Descripción de la vacante

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory document development for FDA, EMA, MHRA and other global authorities. The role reports to the VP, Regulatory Affairs and collaborates with cross-functional teams and external vendors.

The successful candidate will author and review Clinical Overview, Clinical Summary, orphan-drug applications, pediatric plans, and responses to health authorities, ensuring adherence to ICH/GCP guidelines and regulatory

Formación

• MS/PhD/PharmD or equivalent in life sciences.
• 8+ years of medical writing experience in biotech/pharma/CRO.
• Proven track record authoring regulatory submissions for FDA/EMA/MHRA.
• Strong knowledge of ICH guidelines, GCP, and global regulatory standards.
• Ability to independently lead complex document programs with cross-functional teams.

Responsabilidades

• Lead development of regulatory documents for FDA, EMA, MHRA and other agencies.
• Author or oversee Clinical Overview, Clinical Summary, orphan-drug applications, pediatric plans, and responses to health authorities.
• Partner with Regulatory Affairs for meetings and interactions with EU/UK regulators.
• Ensure documents align with ICH guidelines and regulatory requirements.
• Support CTAs, regulatory amendments, annual reports, and MAAs in global programs.

Conocimientos

Medical writing leadership

ICH guidelines & GCP knowledge

Regulatory submissions

Cross-functional collaboration

Educación

MS/PhD/PharmD in life sciences

Descripción del empleo

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory document development for FDA, EMA, MHRA and other global authorities. The role reports to the VP, Regulatory Affairs and collaborates with cross-functional teams and external vendors.

The successful candidate will author and review Clinical Overview, Clinical Summary, orphan-drug applications, pediatric plans, and responses to health authorities, ensuring adherence to ICH/GCP guidelines and regulatory