Senior Manager, Medical Writing
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $133,800 - $178,800 per year
Job Level
Senior
About the role
- This position is responsible for the development of patient safety narratives for Phase 1-4 clinical trials in accordance with the client’s controlled processes based on data listings and/or safety reports (eg, CIOMS).
- Narrative Writing: Writes, edits, reviews, finalizes, and tracks patient safety narratives based on data listings and/or safety reports (eg, CIOMS) provided by the client.
- Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness.
- Identifies crucial discrepancies between the clinical and safety databases, investigates discrepancies and provides recommendations regarding relevance and resolution.
- Be able to handle multiple narratives at the same time to provide finalized documents which incorporate client/vendor medical reviews as well as any Quality Control (QC) findings.
- Ensures the work is complete and of high quality, including final quality control checks, compilation, and formatting.
- Participates in or leads process improvement activities to develop patient safety narrative capabilities.
- Ensure adherence to regulatory requirements and internal quality standards.
- Project oversight: Ability to manage timelines and quality of work using strong organizational, communication, and facilitation skills.
- Builds connection with study team(s) and other related departments to develop safety narrative scope, provide and maintain narrative tracker for each project/study.
- Responsible for leading and coordinating external vendors to ensure successful delivery of projects within defined timelines, budgets, and quality standards.
- Involved in strategic planning, financial oversight, and proactive risk management to support organizational goals.
- Support for medical review and accuracy of narratives, as appropriate.
Requirements
- Advanced degree (MS/PhD/PharmD/MD) in life science/pharmacy/medical/health-related science is preferred.
- MS with a minimum of 5+ years of narrative writing (or equivalent) experience.
- PhD/PharmD/MD with a minimum of 3+ years of clinical safety narrative (or equivalent) experience.
- Prior pharmaceutical, biotechnology, or contract research organization experience.
- Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process.
- Basic knowledge of electronic Common Technical Document (eCTD) requirements.
- Demonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write concise unambiguous medical text in English.
- Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews.
- Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.
- Experience with automation tools for the development of narratives.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
narrative writingclinical safety narrativesdata listingssafety reportsquality controlprocess improvementrisk managementmedical revieweCTD requirementsconcise medical text writing
Soft skills
organizational skillscommunication skillsfacilitation skillsinterpersonal skillsteam collaborationproblem-solvingattention to detailtime managementleadershipproject management
Certifications
advanced degree (MS/PhD/PharmD/MD)