Medical Writing Director for Regulatory Submissions

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary based on experience

Performance-based bonus

Company pension scheme

Private Health Insurance (100% paid)

Life and Critical Illness Insurance

Corporate Gym membership

Regular team building events

Job summary

Cycle Pharmaceuticals Ltd seeks an experienced Medical Director to lead clinical and regulatory writing within our Cambridge R&D team. You will own key documents from Phase 3 protocols to post‑approval submissions, balancing hands-on authoring with oversight of external partners.

You will collaborate across Regulatory, Clinical Operations, and Medical Affairs to ensure submissions are robust, compliant and clearly communicated for successful regulatory outcomes.

Qualifications

• Extensive experience in clinical and regulatory medical writing.
• Lead authorship of Phase 3 protocols and clinical study reports.
• Experience writing NDA, BLA or MAA CTD summaries and integrated summaries.
• Familiarity with ICH guidelines (E3/E6/E9) and eCTD structure.
• Experience managing outsourced writing providers or freelancers.

Responsibilities

• Lead authoring of pivotal Phase 3 clinical documents (protocols, amendments, ICFs, CSRs).
• Prepare clinical content for FDA meetings and marketing applications (briefing packages, regulatory responses).
• Collaborate with Clinical Operations and CROs to ensure data support is clear and accurate.
• Lead Protocols and reports for Phase 4 and post-approval studies.
• Prepare post‑approval submissions and support Pharmacovigilance with safety reports.
• Develop and maintain writing standards, templates and QC processes with Regulatory.

Skills

Regulatory writing

Clinical writing

Project management

Stakeholder management

Outsourced writing management

Education

Life sciences degree

PhD preferred

Tools

Veeva Vault

Job description

Cycle Pharmaceuticals Ltd seeks an experienced Medical Director to lead clinical and regulatory writing within our Cambridge R&D team. You will own key documents from Phase 3 protocols to post‑approval submissions, balancing hands-on authoring with oversight of external partners.

You will collaborate across Regulatory, Clinical Operations, and Medical Affairs to ensure submissions are robust, compliant and clearly communicated for successful regulatory outcomes.