Senior Medical/Regulatory Writer — Strategy & Submissions

Immunocore; Radnor (Delaware County); On-site; USD 158,000 - 185,000; Full time

Job summary

Immunocore is seeking a Senior Manager, Medical/Regulatory Writer to lead the regulatory writing for programs from first‑in‑human studies through to product registration. This role involves collaboration across multiple functions to ensure quality in all regulatory documents.

Successful candidates will have a strong background in medical writing with 4–7 years of experience, proficiency in MS Word and Adobe Acrobat, and a keen understanding of regulatory requirements.

Qualifications

• Track record in writing medical research documents, including protocols and clinical study reports.
• Understanding of global regulatory requirements for writing strategy.
• Experience supporting global clinical studies as a writer.

Responsibilities

• Lead and oversee medical and scientific regulatory writing for assigned programs.
• Authoring clinical study protocols and regulatory documents for Health Authority submissions.
• Perform quality control review of documents in regulatory submissions.

Skills

Medical writing

Regulatory submissions

Communication skills

Attention to detail

MS Word proficiency

Education

BS in relevant field

4–7 years experience in medical/regulatory writing

Tools

Adobe Acrobat

eDMS/RIMS

Job description

Immunocore is seeking a Senior Manager, Medical/Regulatory Writer to lead the regulatory writing for programs from first‑in‑human studies through to product registration. This role involves collaboration across multiple functions to ensure quality in all regulatory documents.

Successful candidates will have a strong background in medical writing with 4–7 years of experience, proficiency in MS Word and Adobe Acrobat, and a keen understanding of regulatory requirements.