Director of Operations
NJM Insurance Group
Senior Manager, HEOR Value Writing
Amgen
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $147,124 - $173,540 per year
Job Level
Senior
About the role
- Prepares, edits, and finalizes key HEOR documents such as Global Value Dossiers, Briefing Books for early HTA advice, AMCP dossiers, EU Joint Clinical Assessment dossiers – in close collaboration with the HEOR Product Lead and cross-functional team. Provides writing support for study protocols, synopses, abstracts, posters, presentations, and manuscripts. Collaborates with clinicians, clinical scientists, biostatisticians, etc. to ensure study results and statistical interpretations are accurately and clearly reflected in the relevant HEOR documents. Is a proficient user of AI authoring tools for drafting, updating and finalizing HEOR documents. Identifies changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. Ensures that value writing deliverables conform to all relevant internal and external guidelines – depending on the specific deliverable. Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant value writing deliverables. Supports development of training materials for onboarding new value writers; ensures consistent application of writing best practices. Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system. Ensures that appropriate documented quality control (QC) checks are performed on value writing deliverables, responds to findings, and recommends quality process improvements.
Requirements
- Doctorate degree and 2 years of medical writing in Biotechnology, Pharmaceutical, or another Healthcare-related field Master’s degree and 4 years of medical writing in Biotechnology, Pharmaceutical, or another Healthcare-related field Bachelor’s degree and 6 years of medical writing in Biotechnology, Pharmaceutical, or another Healthcare-related field Associate’s degree and 10 years of medical writing in Biotechnology, Pharmaceutical, or another Healthcare-related field High school diploma / GED and 12 years of medical writing in Biotechnology, Pharmaceutical, or another Healthcare-related field Excellent English (native if possible) and very good writing and word processing skills Comfortable communicating with people from a range of backgrounds, internally and externally. Excellent attention to detail when preparing/editing documents as well as when reviewing clinical data Experience in working in cross-functional teams within a matrix organization. Experience using various word-processing/text editing/ reference management tools.
