Description
One of Real Staffing Group's clients is in need of a drug development project manager to lead 1) early stage drug development projects that include pre-clinical (animal) studies, drug substance and drug product development, clinical development and US and EU regulatory submissions. 2) can oversee the initiation of Phase 4 clinical studies (this is NOT a clinical project manager, but one that knows all the issues around getting a study up and running, regulatory requirements and clinical supply requirements). 3) need someone who can work within the Med Affairs department (they are faced with getting ready for a product launch) with coordinating scientific publications, preparation of materials for clinical advisory boards with research and practicing M.D. leaders in the pulmonary field.Specific Accountabilities
- Provide project management and leadership to multiple multi-functional project teams.
- Develop fully integrated project plans and schedules that clearly identify the critical path.
- Track and monitor project activities and milestones while maintaining project schedules; communicate variances; prepare and present updates to the Project Team and management when appropriate.
- When appropriate, track and monitor the project budget and variance.
- Schedule, conduct, and facilitate team meetings; record project team meeting minutes and ensure clarity on decisions, deliverables, action items, and timelines.
- Direct project communications and ensure that all project stakeholders are fully informed and knowledgeable about project plans, goals, status, and decisions.
- Collaborate with Finance to support the annual budget process and provide project data to ensure that the budget matches the project goals.
- Ensure that information is communicated within the project teams and to functional management.
- Ensure that any corporate policies and processes are implemented at the project team level.
Key Skills
- Project management expertise and leadership
- Thorough understanding of the drug development and regulatory processes
- Ability to combine attention to detail with big picture perspective
- Strong team management skills, including facilitation, conflict resolution, and team development
- Effective relationship-building skills
- Excellent written and oral communication skills
- Strong computer skills, including Microsoft Project
To find out more about Real please visit www.realstaffing.com