Associate Director, Medical Writing — Oncology

Summit Therapeutics; United States; Remote; USD 80,000 - 160,000; Full time

Job summary

Summit Therapeutics Inc. in the United States seeks an Associate Director of Medical Writing to lead the creation of regulatory documents for a clinical development program, ensuring accuracy, completeness, and regulatory compliance.

The role involves coordinating with biometrics, clinical operations, drug safety, and regulatory affairs to deliver high-quality submissions on time, while refining writing processes and templates for efficiency in a fast-paced environment.

Qualifications

• BA/BS in a scientific field required; advanced degree preferred.
• 8+ years of regulatory medical writing experience in pharma or related org.
• Experience writing protocols, CSRs, investigators' brochures, IND/NDAs.
• Oncology knowledge preferred.
• Excellent writing skills and understanding of drug development and regulatory guidelines.
• Ability to write and edit complex material accurately and clearly.
• Strong attention to detail, multitasking, prioritization, and flexibility.
• Excellent communication in cross-functional teams.
• Ability to analyze and synthesize complex scientific information.

Responsibilities

• Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
• Manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
• Facilitate comment resolution and adjudication with authors, reviewers, and project teams
• Participate in the refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high- quality medical writing deliverables

Skills

Regulatory writing

Regulatory submissions

Cross-functional collaboration

Attention to detail

MS Office

Adobe Acrobat

Education

BA/BS in scientific field

PhD/PharmD/MS preferred

Tools

EDMS systems

Templates & style guides

Job description

Summit Therapeutics Inc. in the United States seeks an Associate Director of Medical Writing to lead the creation of regulatory documents for a clinical development program, ensuring accuracy, completeness, and regulatory compliance.

The role involves coordinating with biometrics, clinical operations, drug safety, and regulatory affairs to deliver high-quality submissions on time, while refining writing processes and templates for efficiency in a fast-paced environment.