What are the responsibilities and job description for the Project Coordinator - Regulatory CMC position at Proclinical Staffing?
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:
- Develop project plans and timelines with a CMC focus, identifying key tasks and resources.
- Maintain and update project plans and timelines.
- Track deliverables and manage project communication tools such as agendas and action items.
- Coordinate RA CMC infrastructure and capability building projects.
- Assist in integrating project management tools to ensure accurate RA CMC timelines.
- Provide administrative support, including meeting planning and logistics.
- Contribute to the development of best practices and standardized processes.
- Maintain the project dashboard.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
