Regulatory Process Lead

Employer
Merck
Location
Upper Gwynedd, PA, US
Posted
February 23 2018
Organization Type
Pharma
Requisition ID: REG003585

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 Health Registration Management  (HRM) Process Lead is a key role supporting Merck’s global registration & licensing information. This individual will be responsible for activities that ensure that tools, systems and procedures align with business process and information needs for to support all regulatory functions and customers globally. Collaborates with functional area contacts and process owners to develop business-related documentation, and evaluate critical key performance indicators.  Support resolving issues and questions that may be encountered by both internal and outsourced data entry staff.


Responsibilities include but are not limited to:

  • Lead HRM-related process and system improvement initiatives that will influence and lead to new capabilities and will drive greater effectiveness and efficiencies
  • Support functional areas and process owners to ensure ongoing system training and documentation meet business needs
  • Perform analysis and work with business partners to translate HRM-related objectives into well-defined requirements in order to support change and innovation within the HRM arena
  • Work with functional areas to facilitate problem solutions while considering regulatory requirements and other functional area requirements and perspectives
  • Develop relationships with internal and external stakeholders in order to obtain and share information that will benefit the overall efforts of the HRM organization
  • Assist with the strategy to support change management activities including evaluation and adoption of new capabilities by end-users
  • Monitor and review HRM-related process measures in order to identify any gaps or discrepancies.  Assist, as needed, with change efforts to address these gaps/ discrepancies.  Communicate with impacted stake holders to ensure they stay informed

Qualifications

Education: 

  • Bachelor’s degree with 8 years of industry experience, with 4 years in a Regulatory area and experience with technical systems in a regulated environment OR Master’s Degree and a minimum of 6 years of industry experience, with 3 years in a Regulatory area and experience with technical systems in a regulated environment.


Required:

  • Broad range of knowledge of regulatory processes as well as related systems, and business requirements
  • Demonstrated experience assessing and enabling process change
  • Ability to lead and influence others outside of a direct reporting relationship
  • Demonstrated collaborative skills and ability to work in cross-functional and international environments


Preferred:

  • Advanced knowledge and capabilities applying technology within a business environment
  • Sigma Black Belt, Change Management Certification, PMI Certification.
  • Experience supporting and working with tools and systems used in the Regulatory Affairs environment


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.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck