Associate Director, Regulatory Affairs - CMC Project Manager Job - United States
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 & Clinical Safety (GRACS) CMC Executive Leadership Team member, 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 multifaceted CMC projects such as managing detailed CMC timelines and deliverables across multiple workstreams.
The Project Manager responsibilities include but are not limited to:
- Manage projects related to regulatory CMC deliverables and submission timelines as the primary responsibility. The candidate may also manage 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.**
- Bachelor’s degree, in a related discipline
- Master’s or advanced degree with at least 2 years of experience in pharmaceutical industry
- A minimum of 2 years of experience within a healthcare/consumer care 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)
- 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
- Experience in Regulatory Affairs and/or R&D as a project manager
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 firstname.lastname@example.org.
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Job: Regulatory Affairs - CMC
Job Title:Assoc. Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Project Manager, Regulatory Affairs, Manager, Law, Compliance, Technology, Legal, Management