Job Description
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 and 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, and 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 and planning meetings/workshops.
* Contribute to the development of best practices and standardized processes.
* Maintain project dashboard.
* Ability to prioritize multiple projects.
* Proficient in project management related technical systems (i.e. Smartsheets, MS Project, Visio, 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, and data mine.
* Excellent organizational and meeting management 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:
* 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.
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