Director, Medical Writing

Immunocore; Gaithersburg (MD); Remote; USD 90,000 - 160,000; Full time

Job summary

Join a pioneering T cell receptor biotechnology company as a Director of Medical Writing. This role leads document strategy and ensures compliance with regulatory guidelines for global submissions. You'll oversee the authoring and review processes, manage timelines, and collaborate with internal and external writers. The company fosters an innovative environment dedicated to developing transformative medicines for oncology and autoimmune conditions. If you have a passion for science and a commitment to excellence, this opportunity is perfect for you.

Qualifications

• 8-12 years experience in medical/scientific writing within pharma/biotech.
• Strong knowledge of drug/biologic development and GxP principles.

Responsibilities

• Lead authoring and review of regulatory documents like protocols and CSRs.
• Manage timelines for document development and approvals.

Skills

Medical Writing

Leadership Skills

Project Management

Regulatory Knowledge

Communication Skills

Attention to Detail

Proficiency in Microsoft Office

Document Management

Education

Bachelor’s in a Scientific Discipline

Advanced Degree (Preferred)

Tools

Electronic Document Management Systems

Job description

Key Responsibilities

The Director, Medical Writing will lead document strategy, overseeing authoring, review processes, and writing assigned documents. They will coordinate internal and external writers, establish best practices for high-quality preclinical summaries, clinical, and regulatory submission documents, ensuring compliance with ICH/GCP/regulatory guidelines for global health authority submissions such as IND/CTA/BLA.

1. Lead planning, authoring, and review of regulatory documents (e.g., Protocols, CSRs, IBs, briefing documents).
2. Evaluate and review documents generated by internal and external writers for consistency, formatting, and scientific accuracy.
3. Engage with external stakeholders including vendors and thought leaders as needed.
4. Manage timelines for document development and approvals.
5. Assess medical writing needs and ensure resources are adequate for timely completion.
6. Oversee document management from draft to final version, including review coordination and style adherence.
7. Support development and improvement of best practices, SOPs, and templates.
8. Lead matrix teams effectively.
9. Maintain a track record of developing high-quality scientific and regulatory documents such as protocols, study reports, and responses to regulatory questions.
10. Deep knowledge of drug/biologic development and GxP principles.
11. Strong leadership, planning, and project management skills.
12. Collaborate effectively to resolve comments and meet deliverables.
13. Manage multiple projects in a fast-paced environment, adaptable to changing priorities.
14. Excellent communication skills and attention to detail.
15. Self-motivated with the ability to work independently.
16. Proficiency in Microsoft Office and electronic document management systems.
17. Experience responding to audits.
18. Educational background: Bachelor’s in a scientific discipline; advanced degrees preferred.
19. Experience: 8-12 years (Bachelor's level) or 6-8 years (advanced degree) in medical/scientific writing within pharma/biotech.

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About the Company

Immunocore (NASDAQ: IMCR) is a pioneering T cell receptor biotechnology company focused on developing transformative medicines for oncology, infectious diseases, and autoimmune conditions. Our R&D leaders are recognized globally for success in drug development. We foster an innovative environment dedicated to delivering first-in-class biological therapies using our soluble TCR platform, including ImmTAX molecules that harness the immune system to treat diseases with high unmet medical needs.

At Immunocore, we value our employees and embrace our core principles of Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE). We are committed to creating an inclusive workplace where everyone is valued, respected, and empowered. We encourage applications from individuals of all backgrounds, supporting our mission to develop breakthrough therapies and transform patients’ lives.