Associate Director, Medical Writing
Summit Therapeutics Inc.
WorldwideFully remoteFull TimeSeniorHealthcare & Telemedicine
USD 10–20 an hourPosted 4 hours ago4h agoApply link checked 4 hours ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 4 hours ago · apply link checked 4 hours ago
About the role
Responsibilities
- Prepare, edit, and finalize clinical/regulatory documents including protocols, CSRs, and Investigator's Brochures
- Interact with cross-functional contributors to acquire necessary input
- Manage document review processes and timelines
- Facilitate comment resolution and adjudication with project teams
- Participate in the refinement of medical writing processes and SOPs
Requirements
- BA/BS degree in a scientific field (PhD, PharmD, or MS preferred)
- 8+ years of regulatory medical writing experience in the pharmaceutical industry
- Experience writing clinical study protocols, CSRs, and IND/NDA submissions
- Knowledge of oncology disease areas preferred
- Proficiency in MS Office, Adobe Acrobat, and electronic document management systems
- Ability to manage multiple projects simultaneously with minimal direction
About the Company
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies in oncology.
What we look for
- BA/BS in scientific field
- 8+ years regulatory medical writing experience
- Experience with protocols, CSRs, and IBs
- Proficiency in MS Office and Adobe Acrobat
- Strong communication skills
OncologyRegulatory Affairs
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Summit Therapeutics Inc.
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