Global Regulatory Affairs - CMC Portfolio Manager

Date: Mar 9, 2019

Location: West Point, PA, US

Apply now »
Requisition ID: REG004241

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. 


Under the guidance of the Global Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) Portfolio Lead, the CMC Portfolio Manager will be responsible for overall design, management, and tracking of the CMC portfolio including regulatory CMC milestones and demand assessment across a product portfolio of ~300 products.  The portfolio manager will develop and maintain tools such as, dashboards to enable portfolio visibility to projects to enable optimized CMC resource management and prioritization, VBA enabled MS Excel, etc.  The portfolio manager will also support project management activities as needed for select high priority, complex products to manage detailed CMC timelines and deliverables.

The CMC Portfolio Manager responsibilities include but are not limited to:
  •  Lead the design and management of a detailed portfolio view of products with the aid of identified stakeholders and output from submission management systems
  •  Initiate and lead discussions with CMC Product Leads to develop project information
  • Collaborate with other functions in Global Regulatory Affairs including Resource Management, Business Operations, Information Management and Portfolio Management to drive for alignment and optimized communications.
  • Manage the CMC Change Initiative portfolio within overall Global Regulatory Affairs portfolio management forums, proactively identifying intersections and representing an integrated view of the business  
  • Develop and maintain appropriate tools/dashboards and establish key metrics to provide visibility on portfolio milestone progress and capacity.
  •  Communicate portfolio status and escalate issues to senior CMC leadership and Global Regulatory Affairs leadership, as needed
  •  The candidate will also support project management activities as needed for select high-priority, complex products in collaboration with the CMC Product Lead to manage CMC timelines and deliverables.
  •  The incumbent may be requested to manage projects that impact business processes, organizational operations, and/or resource management capabilities to support overall Global Regulatory Affairs CMC operations.
The candidate may be required to travel to other Merck sites on a periodic basis.

Qualifications

Education Minimum Requirement: 
  • Bachelor’s degree, in a related discipline, with at least 10-15 years of experience within a healthcare/consumer care industry business/financial operations, performance management or project management  
Required Experience and Skills: 
  • Technically skilled in 1 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 Spotfire for reporting)
  • Ability to act independently and drive initiatives 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.
  •  Exposure to regulatory affairs and/or pharmacovigilance, either through direct experience, or via a role in R&D or manufacturing
  • Proven ability to lead and implement multiple ambiguous projects/tasks simultaneously with minimal oversight, while navigating competing and/or changing priorities
Preferred Experience and Skills:
  • Experience in Regulatory Affairs and/or R&D as a project manager
  • Experience with .NET framework, .NET programming language like C# or VB, .NET libraries like ADO.NET, Entity Framework, RDBMS like MS-SQL, Oracle
  •  Master’s or advanced degree with at least 10-15 years of experience in pharmaceutical industry.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Regulatory Affairs - CMC
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: none
Company Trade Name: Merck


Nearest Major Market: Philadelphia

Apply now »