Vacancy expired!
- Acts as the project manager for assigned projects of simple to moderate complexity.
- With little to some guidance from the Development Project Management leader, develops and manages project plans, manages project timelines, communications, meetings, and other interactions to ensure project deliverables are met on time, to the quality expected, and within budget.
- Typically manages multiple projects simultaneously and is expected to play a key role in ensuring cross-project synergies are realized.
- May support building Pop PK dataset and process flow, document drafting, ClinPharm timeline in NDA/BLA
- Leads coordination of document drafting with Medical Writing, Regulatory Project Management, and the ClinPharm team and multiple stakeholders and contributors
- Manages timelines based on submission plans and internal review process
- Manages deliverables supporting submissions including Pop PK Exposure Data, Pop PK Report, Summary modules, Part 11 Files used to derive Pop PK data, etc.
- 5+ years relevant experience with BA/BS
- 3+ years relevant experience with MA/MS/MBA
Vacancy expired!