Contract
Project Coordinator - Regulatory Affairs, CMC
BioPharma Consulting JAD Group
Cambridge, massachusetts
BioPharma Consulting JAD Group is seeking a motivated Project Coordinator specializing in Regulatory Affairs, CMC (Chemistry, Manufacturing, and Controls). This role will work closely with and support the existing RA CMC Project Manager with various project coordination/project management tasks to ensure all RA CMC Team projects and global regulatory submissions stay on track in alignment with overall Alnylam and Program Team objectives.
Responsibilities:
- Contribute to the development of project plans and timeline with a CMC focus, including defining key tasks, resources, critical path items, gating activities.
- Maintain and update existing project plans and timelines
- Track deliverables
- Develop and disseminate project communication tools (agendas, minutes, action items)
- Participate in and coordinate RA CMC infrastructure and capability building projects.
- Assist in building cross-links between various...