PROJECT COORDINATOR - REGULATORY AFFAIRS, CMC

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 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.

Requirements

Qualifications