What are the responsibilities and job description for the Project Coordinator - Regulatory CMC position at Proclinical?
Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role)
Proclinical is seeking a Project Coordinator to join the Regulatory Affairs - CMC Team.
Primary Responsibilities :
The successful candidate will provide high-level project management support, working closely with the RA CMC Project Manager to ensure that all team projects and global regulatory submissions align with program objectives. Your focus will include early phase, late stage, commercial, and life cycle management projects, as well as capability building and process improvement initiatives.
Skills & Requirements :
- Bachelor's degree with experience in Project Coordination / Management, IT, or biotechnology / pharmaceutical industry.
- Basic project management skills, including problem-solving and prioritization.
- Proficiency in project management systems like Smartsheets, MS Project, Visio, Excel, and SharePoint.
- Experience with Think-Cell, Milestones Professional, OnePager is a plus.
- Ability to quickly learn IT systems and navigate data.
- Strong organizational, communication, and interpersonal skills.
- Familiarity with regulatory filings and CTD structure / content is advantageous.
The Project Coordinator - Regulatory CMC's responsibilities will be :
