Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
GRACS CMC PROGRAM MANAGER (ASSOCIATE DIRECTOR)
West Point, PA Job #REG004053
Under the guidance of the Global Regulatory Affairs & Clinical Safety - Chemistry, Manufacturing & Controls (GRACS CMC) Program Management Office Executive Director, the CMC Program Manager will be responsible for overall management, direction, coordination, implementation, execution and completion of GRACS CMC projects. The CMC Program Manager will progress multifaceted CMC projects such as managing detailed regulatory CMC timelines and deliverables across multiple workstreams, and serving as a member of CMC Product Team(s).
The Program Manager responsibilities include but are not limited to:
- Manage projects related to CMC submission timelines and deliverables or projects that impact business processes, organizational operations, and/or resource management capabilities to support overall Global Regulatory Affairs CMC operations. - Lead the planning and creation of a detailed project plan for projects with input from identified stakeholders - Initiate and lead discussions to facilitate the refinement of the project scope, goals, and deliverables - Manage a full scale project plan with tasks through collaboration with functional representatives - Identify appropriate resources for each task through collaboration with functional representatives - Facilitate project discussions to ensure progress and identify appropriate team actions and risks - Ensure project tasks are completed and necessary action plans are executed on to ensure progress and manage risks - Meets project objectives through management of scheduling conflicts, resource constraints, and financial forecasting - Create and manage project artifacts during all phases of the project (e.g. charter, project plan, close out report, etc) - Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate - Track project deliverables through appropriate tools and framework; report to all project stakeholders - The candidate may be required to travel to other Merck sites on a periodic basis.
Education Minimum Requirement:
- Bachelor's Degree, in a related discipline, with at least 8 years of experience within a healthcare/consumer care industry business/financial operations, performance management or project management
Required Experience and Skills:
- Experience in one or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and with associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting) - Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines. - Capability to work effectively in matrix organizational structures. - Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. - Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing
Preferred Experience and Skills:
- Experience in Regulatory Affairs and/or R&D as a project/program manager - Master's or advanced degree with at least 8 years of experience in pharmaceutical industry.
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