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Entry LevelFull-time
Salary Range
$25,500 - $34,500 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are seeking a CMC/Technical Operations Program Manager to lead international cross-functional technical CMC teams. This role is responsible for delivering all required technical documentation supporting an approvable NDA Module 3 and translating technical & regulatory strategies into execution.
Key Responsibilities
- →Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation
- →Project manage all key CMC deliverables, including underlying reports, and coordinate team interactions
- →Ensure team meetings have structure and purpose, document clear decisions/actions, and communicate them to team members and relevant stakeholders
- →Facilitate the setting and tracking of program objectives and priorities, and monitor program progress against approved project plans
- →Coordinate the identification and mitigation of program issues and risks, and assure risk mitigation plans
- →Build holistic, scientifically sound and relevant scenarios as decision proposals at all governance levels
- →Coordinate the review process of technical documents such as protocols, reports, master and executed batch records, change controls, deviations, etc.
- →Coordinate the preparation for governance and executive management program presentations in close collaboration with the leadership team
- →Responsible for program budget and long-term projections, including budget planning and tracking, and evaluating project resource requirements
- →Follow invoices and confirm the corresponding work execution to the budget owner
Requirements
- ✓Experience leading international cross-functional technical CMC teams
- ✓Strong project management skills with the ability to manage all key CMC deliverables
- ✓Ability to facilitate the setting and tracking of program objectives and priorities
- ✓Experience with risk identification and mitigation planning
- ✓Strong understanding of technical documentation and regulatory requirements
- ✓Experience with program budget planning and tracking
- ✓Excellent communication and stakeholder management skills
