Clinical Supply Chain ConsultantJuly 24, 2019
Role and Responsibilities
In this position the project manager will support clients in a variety of ways:
- Must be able to coordinate resources including, but not limited to, managing internal resources and expanding project scopes for the client where applicable.
- Management of CMC groups (both internal and external), and directing CMC activities for multiple programs if required.
- Establishing and managing vendors for drug substance manufacturing, drug product fill finish, knowledge of clinical packaging and distribution to meet client timelines is a plus.
- Oversee and coordinate activities in support of authoring CMC sections for a variety of regulatory filings.
- Using DSI or client specific systems to track and report on project progress and milestones.
- Manage small teams of Subject Matter Experts with various skill sets to achieve clients’ objectives.
- Track program budgets against a defined scope of work.
- Must be able to manage more than one client and project at a time.
Qualifications and Education Requirements
- Candidates must have a minimum of 10 years of practical experience in a CMC operations capacity with direct experience in the management of cross functional operations.
- B.S. in the sciences
- Familiarity with regulatory authoring projects
- Experience with process optimization or validation
- Drug development experience
- Understanding of the basics of Supply Chain management
- Understanding of CMO (vendor) selection and product transfer
- Proficient in Microsoft Project, Excel, PowerPoint and Word is a plus
Required Travel Up to 25% if directed by a client