Project Manager
Project Manager
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5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Workload
- Develop & Maintain IND/NDA Submission Content Plans (SCP)
- Develop & Maintain Project Timelines for IND submissions/Initial NDA
- Proactively manage & track toward submission deliverables
- Transfer files for Submission to Publisher
- Provide updates wrt NDA Progress
- Liaise with Regulatory Consultant & Publisher (Reg Ops) on submission deliverables and submission dates
- Oversee progress by other all staff towards timelines & Project goals
Requirements
Activities
- Participate in Weekly Company Team Meeting
- Participate in Meetings with Regulatory Consultants/Experts as necessary
- Participate in Meetings with CRO (P3 CSR) as necessary wrt Timeline
- Establish 1:1 Meetings with CMC Clinical Nonclinical as necessary to manage project
- Establish Meetings with NDA project staff (if applicable)
- Establish Meetings with Publisher
Project management skills
Education
Bachelor s Degree in Pharma.
Employment Type
Full Time
