Senior Medical/Regulatory Writing Lead — Remote

BioSpace; Radnor (Delaware County); Remote; USD 158,000 - 185,000; Full time

Job summary

Immunocore is seeking a Senior Manager, Medical/Regulatory Writer who will lead the medical and scientific regulatory writing for multiple programs, from first-in-human to product registration. This role interacts across regulatory, clinical, translational medicine, and medical affairs to ensure consistent messaging and timely delivery.

The candidate should have a strong regulatory writing background in the pharmaceutical industry, preferably with biologics, and be able to operate in an agile,

Qualifications

• BS with 4-7 years in medical/regulatory writing and 7-10 years in industry.
• Advanced degree (MS/PhD/MD) with 3-5 years of experience.

Responsibilities

• Lead medical and scientific regulatory writing for assigned programs from preclinical to registration.
• Author regulatory documents: Clinical Summaries, Investigator Brochure, DSURs, and briefing documents.
• Coordinate external writers to ensure consistency of messaging and timely delivery.
• QC review of documents for grammar, formatting, and clarity; ensure regulatory compliance.
• Support development of submission documents (IND/CTA, labeling, CTD/BLA/MAA).
• Contribute to medical writing procedures and best practices.

Skills

Medical writing

Regulatory writing

Leadership

Project coordination

Communication

Education

BS in medical/regulatory writing

Advanced degree (MS/PhD/MD etc)

Tools

MS Word

Adobe Acrobat

eDMS/RIMS

Regulatory submission tools

Job description

Immunocore is seeking a Senior Manager, Medical/Regulatory Writer who will lead the medical and scientific regulatory writing for multiple programs, from first-in-human to product registration. This role interacts across regulatory, clinical, translational medicine, and medical affairs to ensure consistent messaging and timely delivery.

The candidate should have a strong regulatory writing background in the pharmaceutical industry, preferably with biologics, and be able to operate in an agile,