Project Coordinator - Regulatory Affairs, CMC

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 client and Program Team objectives.

Under the direction of the RA CMC Project Manager, this role will be involved in many facets of Client s 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 Client 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 Client 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

• 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
• 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.