Senior Manager, Medical/Regulatory Writer
Immunocore
August 17, 2026
Remote friendly (Radnor, PA)
United States
Clinical Research and Development
Responsibilities:
- Lead and oversee medical/scientific regulatory writing for assigned programs from first-in-human through product registration.
- Coordinate cross-functional writing to ensure consistency and quality; provide writing support and contribute to regulatory messaging strategy.
- Author or supervise preparation of regulatory documents for health authority submissions, including: clinical study protocols, clinical summaries (clinical overview, ISS/ISE, PK/PD summary, AC briefing), Investigator Brochure(s), DSURs, briefing documents, responses to health authority questions, and other submission materials.
- Author clinical study reports (CSRs).
- Manage internal/external writing processes; resolve errors/inconsistencies; ensure timely, high-quality deliverables.
- Coordinate external (contract) writers.
- Input into regulatory submission documents (e.g., IND/CTA materials, labeling, CTD/BLA/MAA for eCTD).
- Contribute to medical writing procedures/best practices; maintain controlled archival files.
- Perform assigned QC review (grammar, formatting, clarity, etc.).
Supervision:
- No direct supervisory responsibilities; oversee/coordinate external writers.
Essential Qualifications/Skills:
- Track record writing medical research documents (protocols, CSRs, health authority briefings).
- MS Word (macros/templates) and Adobe Acrobat (bookmarks/hyperlinks).
- Understanding of global regulatory requirements; experience supporting global clinical programs.
- Agile to changing priorities; leadership, communication, attention to detail, organization.
- Maintain document inventory/tracking in eDMS/RIMS.
Preferred:
- Master/sub protocols, umbrella trials, basket studies.
- Short-turnaround RFI responses.
- Experience with eDMS/RIMs and review/collaboration systems.
Education:
- BS with 4–7 years medical/regulatory writing and 7–10 years industry experience; or advanced degree (M.S., PharmD, Ph.D., M.D.) with 3–5 years.
US Salary Range: $158,000–$185,000.
- Lead and oversee medical/scientific regulatory writing for assigned programs from first-in-human through product registration.
- Coordinate cross-functional writing to ensure consistency and quality; provide writing support and contribute to regulatory messaging strategy.
- Author or supervise preparation of regulatory documents for health authority submissions, including: clinical study protocols, clinical summaries (clinical overview, ISS/ISE, PK/PD summary, AC briefing), Investigator Brochure(s), DSURs, briefing documents, responses to health authority questions, and other submission materials.
- Author clinical study reports (CSRs).
- Manage internal/external writing processes; resolve errors/inconsistencies; ensure timely, high-quality deliverables.
- Coordinate external (contract) writers.
- Input into regulatory submission documents (e.g., IND/CTA materials, labeling, CTD/BLA/MAA for eCTD).
- Contribute to medical writing procedures/best practices; maintain controlled archival files.
- Perform assigned QC review (grammar, formatting, clarity, etc.).
Supervision:
- No direct supervisory responsibilities; oversee/coordinate external writers.
Essential Qualifications/Skills:
- Track record writing medical research documents (protocols, CSRs, health authority briefings).
- MS Word (macros/templates) and Adobe Acrobat (bookmarks/hyperlinks).
- Understanding of global regulatory requirements; experience supporting global clinical programs.
- Agile to changing priorities; leadership, communication, attention to detail, organization.
- Maintain document inventory/tracking in eDMS/RIMS.
Preferred:
- Master/sub protocols, umbrella trials, basket studies.
- Short-turnaround RFI responses.
- Experience with eDMS/RIMs and review/collaboration systems.
Education:
- BS with 4–7 years medical/regulatory writing and 7–10 years industry experience; or advanced degree (M.S., PharmD, Ph.D., M.D.) with 3–5 years.
US Salary Range: $158,000–$185,000.