What are the responsibilities and job description for the Project Coordinator - Regulatory Affairs, CMC position at TalentBurst, Inc.?
Industry : Pharmaceuticals
Title : Project Coordinator - Regulatory Affairs, CMC
Job ID : 2025-8974
Location : Cambridge, MA OR Remote
Duration : 12 months contract ( Chances of extension)
Overview :
We are looking for a Project Coordinator to provide consistent, high-level project management support to the Regulatory Affairs – CMC Team. 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 company and Program Team objectives.
Under the direction of the RA CMC Project Manager, this role will be involved in many facets of our regulatory filings including early phase, late stage, commercial, and life cycle management projects. This role will also provide support for RA CMC capability build and process improvement projects.
Collaboration with Regulatory CMC program leads, Regulatory Operations, Global Regulatory teams, IT, project management and operations focused areas of the business will be a key component, and therefore past experience in a business area that utilizes core project management techniques and tools is required (i.e IT, government, logistics, etc.)
Assist in building cross-links between various project management tools within company to ensure RA CMC timelines reflect accurate data
Summary of Key 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 project management tools within company to ensure RA CMC timelines reflect accurate, up-to-date data
- Provide administrative support for RA CMC team including reserving conference rooms, planning meetings / workshops, food, etc.
- Contribute to development of best practices and standardized process.
- Maintain project dashboard
Qualifications
TB_PH
