Responsibilities
- Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 and translate technical & regulatory strategies into execution.
- Project manage all key CMC deliverables, incl underlaying reports, coordinate team interactions ensuring team meetings have structure and purpose, documents clear decisions/actions and communicates them to team members and relevant stakeholders, holds team members accountable for functional delivery of plans
- Assure integrated program plans are in place including cross-functional interdependencies
- Facilitates the setting and tracking of program objectives and priorities and monitors program progress against approved project plans (ensures we deliver on time and on budget)
- Coordinates the identification and mitigation of program issues and risks, assures risk mitigation plans
- Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels
- Coordinate the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)
- Coordinates the preparation for governance and executive management program presentations in close collaboration with the leadership team
- Responsible for program budget and long-term projections – budget planning and tracking, and evaluates project resource requirements: highlights resource gaps and works to ensure they are addressed
- Follow the invoices and confirm the corresponding work execution to the budget owner
- Other job related tasks
Work Arrangement
Hybrid
Team
Structure: international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs
Additional Information
- The role requires periodic travel between both locations to support cross-site collaboration and business needs.
