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Process and System Analyst (Regulatory Portfolio and Submission Management)


Upper Gwynedd, PA
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Job Details

Job Title: Process and System Analyst (Regulatory Portfolio and Submission Management)  - REG003154


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 Process and System Analyst is responsible for promoting a consistent culture of adherence to business process and use of the supporting tools within the Regulatory Portfolio & Submission Management (RPSM) organization, which folds into the broader GRACS organization.  The Senior Specialist is responsible for conducting internal process reviews, monitoring key performance/compliance indicators and facilitating action when metrics fall out of targeted range.    They will monitor both key data points as well as output from tools such as USPT, ORION, and SPARS, utilized by the Submission Management Team in the preparation of worldwide regulatory submissions.  They will help to ensure appropriate training and work instruction resources are available and updated to enable quality and compliant submission planning/ documentation.  Additionally, they will assist in notifying the organization of upcoming internal and external inspections and audits related to regulatory submission planning, preparing the supporting documentation requests, and tracking any corrective and preventative actions (CAPA) to ensure their completion in a timely manner.  The Senior Specialist is responsible for assisting with non-compliance investigations and quality deviations which include root-cause analysis in an effort to problem solve and help drive process improvement.   They will also assist in the tracking of risk mitigation plan development and mitigation activities.


Primary Activities

  • Performs process reviews and system checks to ensure high quality and compliant global submissions
  • Assists with monitoring key performance indicators (KPI) and compliance indicators (KCI); performing trend analysis; evaluating issues for root-cause; and communicating findings to RPSM Team members.  Supports resolution of those metrics which are considered to be outside acceptable boundaries.
  • Helps to identify business process improvement opportunities, documentation updates and/or training to prevent practices which could lead to quality deviations or non-compliance events.
  • Liaises with the GRACS Quality & Compliance, MRL Quality Assurance and other external functional areas as appropriate to support any audit or inspection activities, including CAPA resolution. 
  • Accountable to ensure tracking and completion of corrective and preventative action (CAPA) plans stemming from inspection, audit and non-compliance investigations.  Ensure appropriate evidence to support closure has been collected, documented and reported to GRACS Quality & Compliance as necessary.


Education  Requirement:

  • Bachelor Degree

Required Experience:

  • Knowledge and understanding of quality and compliance systems
  • At least 5 years of operations experience with a minimum of 3 years in compliance and quality
  • Ability to lead by influence and work effectively in matrix organizational structures
  • Ability to communicate effectively, both verbally and written, with others across levels of the organization
  • Ability to understand details, but keep overall "big picture" view of projects and strategies
  • Knowledge of Sigma methodology and corresponding toolsets
  • Highly organized individual with keen attention to detail

Preferred Experience:

  • Regulatory experience

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 


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

Employee Status Regular

Number Of Openings 1

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