Senior Manager, Medical Writing
Summit Therapeutics, Inc.
full-time
Posted on:
Location Type: Office
Location: Miami • Florida • United States
Visit company websiteExplore more
Salary
💰 $158,000 - $185,000 per year
Job Level
About the role
- Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigators 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
Requirements
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 5+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, and investigators brochures
- Knowledge of oncology disease areas preferred
- Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
- Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
- Excellent attention to detail, multitasking, prioritization, and flexibility
- Excellent communication skills with proven ability to interact in a cross-functional environment
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
- Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates.
- Strategic thinker with strong analytical skills and ability to work in a fast-paced environment
Benefits
- 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory medical writingclinical study protocolsclinical study reportsinvestigators brochuresdrug development processregulatory guidelinesscientific information analysisoncology knowledgedocument review managementmedical writing process refinement
Soft Skills
excellent writing skillsattention to detailmultitaskingprioritizationflexibilitycommunication skillsanalytical skillsstrategic thinkingcross-functional interactionsynthesis of complex information
Certifications
BA/BS degree in scientific fieldPhDPharmDMS