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hace 2 semanas
The Associate Director, GRACS Mature Deal and Operations role is a critical position within the Global Regulatory Affairs team at MSD. This individual will oversee the centralized management of regulatory activities across various contracts and arrangements, ensuring compliance with global, regional, and local regulations.
The incumbent will work closely with the Director of Business Development Execution, Mature Deals and Operations, to provide oversight and maintenance of tools that enable efficient operations for the GRACS Business Development Execution and GRACS Integration teams. This includes consistency and streamlined execution and maintenance of existing and future business partner deals.
A key responsibility of this role is to serve as the point of contact for all alliance management issues, including contractual questions related to ongoing GRACS activities. The Associate Director will also lead the execution and support of ancillary agreement activities, such as divestitures and terminations.
In addition, the incumbent will be responsible for providing ongoing regulatory reporting of status, risks, and issues to Senior Leadership on the contractual obligations and commitments of the GRACS organizations. This includes collaboration with Corporate Business Development, Research & Development Division Global Alliance Management, and GRACS Business Development to comprehend partner agreements and goals post-implementation.
To achieve these objectives, the Associate Director will work closely across GRACS stakeholders, including GRACS Integration Teams and GRACS Business Development, to view and link milestones for a single dashboard view across active divestitures, integrations, and alliances. They will also support a centralized risk and issue tracking mechanism and tool for GRACS across deals.
The ideal candidate will have a strong understanding of regulatory and clinical processes for pharmaceutical products, vaccines, and/or biologic products. They should possess excellent virtual and in-person collaboration skills, demonstrated facilitation and leadership abilities, and clear communication skills. Experience with project management, data analysis, and tool development is also essential.
This role requires a bachelor's degree in a technical, business, or science field, preferably with at least 8 years of experience in the pharmaceutical industry. A minimum of 5 years of experience in a regulatory/pharmacovigilance function or business development is required. Desired qualifications include experience with business development and/or regulatory strategy and process for partnerships, as well as project management certifications like PMP or Six Sigma.
Key Responsibilities:
- Centralized management of regulatory activities across various contracts and arrangements
- Oversight and maintenance of tools for GRACS Business Development Execution and GRACS Integration teams
- Point of contact for all alliance management issues
- Execution and support of ancillary agreement activities
- Providing ongoing regulatory reporting to Senior Leadership
- Collaboration with GRACS stakeholders to view and link milestones
- Supporting a centralized risk and issue tracking mechanism and tool
