Senior Medical Writing Director – Oncology

Summit Therapeutics, Inc.; United States; On-site; USD 14,000 - 28,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory writing efforts for their oncology programs. You will produce high-quality regulatory documents and collaborate with cross-functional teams to ensure alignment with regulatory requirements.

The role requires a BA/BS in a scientific field, 8+ years in regulatory medical writing, and strong writing skills. A PhD/PharmD/MS is preferred.

Qualifications

• BA/BS degree in a scientific field required; advanced degree preferred.
• 8+ years of regulatory medical writing experience in pharma or related org.
• Knowledge of oncology disease areas preferred.
• Excellent writing skills and understanding of drug development and regulatory guidelines.
• Ability to write and edit complex material with high accuracy and clarity.

Responsibilities

• Prepare, edit, and finalize clinical/regulatory documents (protocols, CSRs, IBs, briefing documents, Module 2 submissions).
• Interact with authors, contributors, and reviewers across Biometrics, Clinical Ops, and Regulatory Affairs.
• Manage document review processes and timelines to ensure on-time deliverables.

Skills

Regulatory writing

Regulatory submissions

Medical writing

Cross-functional collaboration

MS Office proficiency

Education

Advanced degree (PhD/PharmD/MS) preferred

Tools

Adobe Acrobat

Electronic document management systems (EDMS)

Job description

Summit Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory writing efforts for their oncology programs. You will produce high-quality regulatory documents and collaborate with cross-functional teams to ensure alignment with regulatory requirements.

The role requires a BA/BS in a scientific field, 8+ years in regulatory medical writing, and strong writing skills. A PhD/PharmD/MS is preferred.