The Manager/Sr. Manager, will represent Nonclinical Writing on project teams, working directly with scientists within the Early Development (eDEV) and Research departments and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to lead the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings.
Summary of Key Responsibilities:
Lead nonclinical writing assignments in conjunction with scientists and project team members for early development/late stage programs in the preparation of nonclinical content in support of regulatory submissions (eg, nonclinical protocols and reports, Investigator’s Brochures, Briefing Documents, INDs, IMPDs, annual reports/DSURs, NDA/MAAs).
Leads document writing and review processes within department for individual projects.
Develops and maintains timelines for document generation, revision, and completion, in collaboration with other project team members and Regulatory Affairs/Operations.
Coordinate and manage review cycles for nonclinical documents in collaboration with subject matter experts, and lead discussions when needed.
Edit/write nonclinical study report drafts from templates and interpret data as needed.
Review and/or edit internal and external publications (eg, manuscripts, abstracts, poster presentations, white papers).
Independently manage outsourced writing staff and projects.
Contribute to the development and maintenance of SOPs, templates, and style manuals.
Provides communication and training on writing requirements and processes, templates, style guides, and SOPs within the department and cross-functionally, as required.
Provides quality control (QC) review of various regulatory and nonclinical documents as needed.
Independently solve problems, exercising sound judgment, appropriate interfacing, and flexibility within a dynamic environment.
Bachelor's degree in Life Sciences with 4+ years’ experience in relevant field. Professional certification/credentials, experience with regulatory submissions is a plus.
In-depth knowledge of Good Laboratory 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 excellent written and oral communication skills.
Must be proficient in Microsoft® Suite (Word, Excel, PowerPoint, Visio). Experience with electronic document management and tracking systems a plus.
Internal Number: ED18R0001
About Alnylam Pharmaceuticals Inc.
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our “Alnylam 2020” guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, and 2017.