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Responsibilities
- Assisting in the management of cross-functional sub teams to facilitate timely planning, execution, tracking, and completion of NDA-related clinical deliverables. Subteams may include individuals from the following functional areas: clinical development, clinical operations, safety, medical affairs, biometrics, regulatory, program management, etc.
- Setting up meetings, drafting agendas and detailed minutes, and tracking actions through completion.
- Assisting in the identification of issues impacting plan execution and working with the team to identify risks and develop mitigation strategies
- Ensuring effective and timely communication to subteam members regarding activity status, key milestones, identified risks and resource allocation
Required Qualifications
- MS or BS Degree in life sciences, healthcare, or related field.
- Minimum of 3 years experience in pharmaceutical or biotechnology drug development with at least 1 year in a project/program management role.
- Experience with phase 2 and/or 3 development program is mandatory.
- Experience in project management supporting cross-functional teams with strong organizational skills.
- Proficiency in project management software and tools (e.g. Smartsheet, SharePoint or similar).
