Project Manager, PDM
The Project Manager will be responsible for providing project management support to the Technical Operations team. Primary responsibilities will include management of commercial programs and post approval life cycle management. The full scope of projects assigned will start with IND, Phase 1 and has the potential to range from IND, Phase 1, 2, 3 to Commercialization. The Project Manager will collaborate with the following groups: CMC, Toxicology, Regulatory, Clinical groups. The PM will provide project activities, timelines, meeting minutes, action items, resource plans and other project documents.
- Develop and manage detailed project timelines
- Monitors project execution and adjusts plans
- Facilitates project communications and documentation
- Collaborates with team to prepare project reviews, product development and lifecycle
- management plans for senior management
- Collaborates with the team to resolve issues and organizes team to execute on the corrective actions.
- Ensures project work complies with established practices, policies, and processes
- Minimum 4 years of relevant experience. Relevant experience consists of work in cross functional bio pharmaceutical /pharmaceutical CMC development, GMP and regulatory affairs
- Excellent organizational skills, capable of setting priorities and delivering on commitments while, managing high workload
- Strong communication skills; written and verbal including oral presentation skills
- Experience in biologics pharmaceutical project management is required
- In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, SharePoint and other reporting/tracking tools
**Part time work, average estimate 3 days/week