Project Manager – MRL ONLY
- Type: VMS
- Job #38736
The primary function includes coordinating various GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.
1. Partner with Business Development Leads responsible for Merck negotiations with external partners and agreements activities that have GRACS organizational impact. Support the definition of the right strategy and approach with the partner to ensure global regulatory compliance.
2. Upon execution of assigned Business Development agreements, ensure communication, and implementation within GRACS functional areas as deals require.
3. Collaborates with all functional areas as well as Business Development Partnership and Supplier Management, Clinical Research, Legal, Alliance Management, and Manufacturing as deals require to identify detailed obligations of each agreement and develop strategies to accommodate such requirements as efficiently as possible. Ensure and/or facilitate assessments to evaluate the organization’s ability to meet those business development execution strategies.
4. Assist in the identification and prioritization of agreements to maintain compliance with worldwide regulatory requirements including but not limited to post-marketing commitments/requirements, renewal regulations, labeling updates, pharmacovigilance.
5. For all assigned Business Development Agreements
a) Act as a project lead and point of contact that require functional area deliverables related to implementation and maintenance across GRACS.
Anticipate internal/external business and regulatory compliance issues, assess problem situations to identify causes, gather and process relevant information, generate possible solutions, make recommendations and/or resolve the problem and direct the resolution of complex business problems. Develop and manage the project plan and facilitate related status meetings. Ensure adherence to the established governance structure including roles and responsibilities and behavioral protocols to encourage collaborations as well as review committees to facilitate decisions and oversight deal’s execution.