Position Overview
We are seeking 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 and project management tasks to ensure all RA CMC Team projects and global regulatory submissions stay on track in alignment with overall program team objectives.

Under the direction of the RA CMC Project Manager, this role will be involved in many facets of regulatory filings, including early-phase, late-stage, commercial, and life cycle management projects. This role will also support RA CMC capability-building 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. Therefore, past experience in a business area that utilizes core project management techniques and tools is required (e.g., IT, government, logistics, etc.).

Key Responsibilities

• Contribute to the development of project plans and timelines 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 to ensure project milestones are met.
• Develop and disseminate project communication tools, including agendas, minutes, and action items.
• Participate in and coordinate RA CMC infrastructure and capability-building projects.
• Assist in integrating various project management tools to ensure RA CMC timelines reflect accurate, up-to-date data.
• Provide administrative support for the RA CMC team, including reserving conference rooms, planning meetings/workshops, and coordinating logistics.
• Contribute to the development of best practices and standardized processes.
• Maintain project dashboards to ensure visibility into project status.

Qualifications

• Bachelor's degree with at least 2 years of experience in one or more of the following: Project Coordination/Project Management, IT, or the biotechnology/pharmaceutical industry.
• Basic project management skills, including the ability to think creatively to solve problems, identify bottlenecks, understand critical paths, and escalate issues appropriately in a timely manner.
• Ability to prioritize multiple projects effectively.
• Proficiency in project management-related technical systems (e.g., Smartsheets, MS Project, Visio, Excel, SharePoint).
• Experience with Think-Cell, Milestones Professional, and OnePager is a plus.
• Demonstrated ability to quickly learn IT systems, navigate metadata, build reports, and perform data mining.
• Excellent organizational and meeting management/facilitation skills.
• Strong communication skills, including both written and verbal communication.
• Strong interpersonal skills and the ability to work in a team environment.
• Exposure to regulatory filings and familiarity with CTD structure/content is a plus.