Senior Manager, Medical Writing
Senior Manager, Medical Writing
Alnylam Pharmaceuticals
Maidenhead, United Kingdom
Summary of Key Responsibilities
The Senior Manager, Medical Writing will collaborate with project teams on the development of clinical pharmacology (main area of focus) and other clinical regulatory documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) and will oversee the work of contract writers on the clinical program.
- Produce high quality and on-time writing deliverables;
- Independently plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, clinical pharmacology and pharmacometric reports, integrated safety and efficacy summaries and related documents;
- Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors;
- Represent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with the program Medical Writing Lead to ensure proper planning and resourcing for upcoming project writing deliverables;
- Collaborate effectively with Clinical Pharmacology, Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders;
- Serve as medical writing expert for clinical pharmacology documents and their production;
- Support the preparation of clinical pharmacology and pharmacometric abstracts and manuscripts;
- Contribute to SOP and template development and maintenance.
Qualifications
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred;
- 5+ years of experience as a medical writer, nonclinical writer, or clinical pharmacology writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA), pharmacology documents (eg, clinical pharmacology sections of regulatory documents, Summary of Clinical Pharmacology, modeling reports), and knowledge of eCTD formatting is a plus;
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process;
- Successful track record of managing multiple projects in a fast-paced and deadline-driven environment;
- Impeccable attention to detail and ability to complete writing assignments in a timely manner;
- Experience overseeing the work of contract writers is a plus;
- Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint;
- Ability to travel approximately 10% is required;
- If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required.
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