Director, Regulatory Affairs - CMC Project Manager- Keytruda Job - United States
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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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Under the guidance of the Global Regulatory Affairs CMC franchise leader (Keytruda), the CMC Project Manager will be responsible for overall management, direction, coordination, implementation, execution and completion of GRACS CMC projects. The CMC Project Manager will progress high priority, multifaceted CMC projects such as managing detailed CMC timelines and deliverables across multiple parallel and intersecting workstreams with significant impact to the business.
The CMC Project Manager responsibilities include but are not limited to:
- Manage projects related to CMC submissions and deliverables or CMC programs that impact business processes, organizational operations, and/or resource management capabilities to support overall Global Regulatory Affairs CMC operations and conformance.
- Lead the planning and creation of a detailed project plan for highly complex 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 in internal and cross-divisional project teams
- 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)
- Proactively identify and resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
- Track project deliverables including change controls 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.
- Bachelor’s degree, in a related discipline, with at least 10 years of experience within a healthcare/consumer care industry business/financial operations, performance management or project management
- Master’s or advanced degree with at least 10 years of experience in pharmaceutical industry.
- Knowledge and experience in one or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and experience with associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
- Exposure to regulatory affairs and/or CMC either through direct experience, or via a role in R&D or manufacturing
- Ability to act independently and drive projects and other requests in a proactive, forward thinking manner.
- 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
- Experience in Regulatory Affairs and/or R&D as a project manager
- Functional understanding of Change Control processes supporting manufacturing operations and CMC dossier management.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Job: Regulatory Affairs - CMC
Job Title:Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Manager, Regulatory Affairs, Project Manager, Law, Pharmaceutical, Legal, Management, Technology, Science