What are the responsibilities and job description for the Project Coordinator - Regulatory Affairs, CMC position at BioPharma Consulting JAD Group?
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:
Qualifications
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 Alnylam 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
- Ability to prioritize multiple projects
- Proficient in project management related technical systems (i.e. Smartsheets, MS Project, Visio, and Excel, SharePoint)
- Experience in Think-Cell, Milestones Professional, OnePager a plus
- Demonstrated ability to learn IT systems quickly and be able to navigate meta-data, build reports, data mine
- Excellent organizational and meeting management/facilitation skills
- Good communication skills, including written and verbal communications
- Strong interpersonal skills and ability to work in a team environment
- Exposure to regulatory filings and familiarity with CTD structure / content a plus
Qualifications
- Bachelor's degree with at least 2 years' experience in one or more of the following: Project Coordination/Project Management, IT, biotechnology/pharmaceutical industry
- Basic project management skills: ability to think creatively to problem solve, identify bottlenecks, understand critical path, and escalate issues appropriately in a timely fashion