Manager of Regulatory Affairs - Life Cycle Management Work with the Global Regulatory Lead and Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regu...
sciences. Clear alignment with Alnylam Core Values...
Contribute to data management activities as a lead study data manager in support of Alnylam clinical studies...
's Degree required, Master's Degree Preferred. Clear alignment with Alnylam Core Values...
, revise, and maintain Company Core Data Sheets (CCDS) for Alnylam's products. Develop labeling strategies and Target Label... on Alnylam's products. Lead with development and maintenance of regional labeling that aligns with the CCDS and meets the...
Responsible for the development of the program-level operational strategy and ensuring alignment across functions, e.g., E2E connectivity across functions, share lessons learned for program-level consistency, and monitor KPIs to track progr...
Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. Provide input on trial level operational strategies for clinic...
Build, lead and mentor the Global Regulatory Policy & Intelligence team across regions;set priorities, operating model, and KPI framework. Align Policy & Intelligence deliverables with corporate R&D and commercial priorities;ensure timely...
Support the Sales Team with regular in-field visits and coaching, aligned to Alnylam's specific customer engagement...
Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. Provide input on trial level operational strategies for clinic...