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Associate Director, Access Operations
hace 2 meses
Job Summary
Novartis Farmacéutica is seeking an experienced professional to lead our Managed Access Programs (MAP) and Post Study Drug Supply (PSDS) operations. As an Associate Director, Access Operations, you will be responsible for planning, executing, and managing MAP and PSDS activities with high quality, adequate resources, and timely and cost-efficiently.
Main Responsibilities
- Lead and oversee the implementation, progress, and close-out activities of assigned MAP and PSDS activities and monitor compliance for reporting.
- Accountable for forecasting and managing drug supply for activities and for activity budget planning, approval, and oversight.
- Accountable for accuracy of MAP and PSDS information in relevant systems.
- Point of contact for MAP and PSDS operational activities for assigned area/product.
- Partner with global and local Medical, Finance, Supply, Quality Assurance, Ethics, Risk & Compliance, and other relevant teams to ensure timely, efficient, and quality planning and execution of MAP and PSDS activities.
Requirements
- At least 5 years of technical, operational, or managerial experience in planning, executing, and reporting Managed or Post Trial Access or clinical trials in a Pharma company or Contract Research Organization.
- Experience in Medical Affairs preferred.
- Experience in working in matrix organizations and international multidisciplinary teams.
- Experience in multiple clinical indications preferred.
- Previous experience leading several MAPs/PTA/trials in parallel.
Skills
- Strong understanding of clinical development activities and functions/roles/responsibilities.
- Advanced understanding of business processes.
- Thorough knowledge of Good Clinical Practice and global drug development process.
- Demonstrated innovation in operational processes and issue resolutions.
- Strong interpersonal, problem-solving, negotiation, communication, and conflict management/resolution skills.
Language
Fluent English, both spoken and written.
