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Senior Specialist Regulatory Affairs


Upper Gwynedd, PA
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Job Details

Job Title: Senior Specialist Regulatory Affairs  - REG003077


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. 


The Global Regulatory Affairs and Clinical Safety (GRACS) Resource Management Sr. Specialist will be accountable for managing the GRACS time reporting process and the associated business analytics for the GRACS organization to support strategic and tactical decisions related to organizational resource requirements/utilization.

This role will support the maintenance, operation, and ongoing evolution of the time reporting process.  This includes generating, collecting, maintaining, and/or tracking specific:

  • Time reporter rosters
  • GRACS time reporting categories
  • Resource utilization metrics
  • Time reporting compliance



  • Bachelor’s Degree

Required Experience:

  • 5 years of working experience in a business planning/forecasting and/or business analytics role
  • Extensive experience with MS Office (specifically: Excel, Access, PowerPoint) and MSPS
  • Strong conceptual and analytical thinking skills
  • Demonstrated ability to manage multiple priorities
  • Demonstrated ability to network, collaborate, and communicate across cultures, organizational levels and disciplines
  • Knowledge of Global Regulatory and/or Clinical Safety processes and work types
  • Demonstrated success on independently leading/delivering on project objectives
  • Proactive and creative problem-solver that generates options, and makes effective and timely decisions
  • Experience with Global Time Tracking process and tools
  • Experience managing, manipulating, and mining large data sets, especially to support the analysis of complex operations

Preferred Experience:

  • Experience with Spotfire and/or other data visualization software packages
  • Resource and capacity management experience
  • Experience working on large-scale, global initiatives
  • Project Management Experience
  • Six Sigma Green or Black Belt
  • Advanced degree

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 an accommodation for the application process please email us at


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.


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




Job Regulatory Affairs Generic

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-NJ-Rahway, NA-US-NJ-Kenilworth

Employee Status Regular

Number Of Openings 1

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