HRM CMC Process Lead, Regulatory Information Management
Location:
Posted:
October 20, 2016
Reference:
REG002620
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.

Description:

The Health Registration Management (HRM) Global Process Lead is accountable for the delivery of an enterprise-wide HRM process strategy to support all regulatory functions globally. The Lead is responsible for strategies that expand the HRM capability to improve overall process compliance, simplify process execution, and extend the reach of HRM support into manufacturing, supply chain, quality and other regulatory-interfacing organizations. The lead is therefore responsible for continued interactions and shared decision making with leaders within GRACS, MMD, GTO, CSSM and GHH. Responsible for the management, coaching and development of HRM's process support team. Provides direction as needed and works to integrate the staff into a matrixed high-performance team.

Responsibilities include but are not limited to:
  • Develop strategies that establish a regulatory information aggregation capability while at the same time supporting local regulatory information requirements.
  • Perform analysis and work with CMC business partners to translate HRM-related objectives into well-defined requirements in order to support product constraint tracking efforts in a manner that optimizes supply chain needs while minimizing activities that typically expose HA violation vulnerabilities.
  • Within the CMC, MMD and Supply Chain areas, work with other functional areas to facilitate problem solutions while considering regulatory requirements and other functional area requirements and perspectives.
  • Interface with vendors to assess and define strategic long-term partnership requirements and establish ongoing rules of engagement.
  • Monitor and review HRM-related process measures in order to identify any gaps or discnon-compliance indicators. Assist, as needed, with change efforts to address these gaps/ discrepancies. Communicate with affected stake holders to ensure they stay informed.
  • Oversee the staff leading key HRM-related process and system improvement initiatives that will influence and lead to improved regulatory compliance and will drive greater effectiveness and efficiencies.
  • Work with HRM Regional Leads to ensure procedures do not perpetuate the current problem of incomplete impact assessment (i.e. site does not update local system to control material that is restricted leading to potential supply disruptions).
  • Provides leadership to a group of Health Registration Management (HRM) Specialists and Business Area Contacts responsible for supporting functional area partners.


Qualifications:
Education Minimum Requirement:
  • Bachelor's degree with 8 years of industry experience, with 4 years in a CMC/ 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 4 years in a CMC/ Regulatory area and experience with technical systems in a regulated environment.
Required Experience and Skills:
  • Knowledge of Regulatory Filing procedures and/or Health Authority Registration process .
  • Broad range of knowledge of regulatory CMC processes as well as overall knowledge of the end-to-end CMC change control processes, related systems, and business requirements.
  • Demonstrated experience assessing and enabling process change.
  • Ability to lead and influence others outside of a direct reporting relationship.
  • Broad organizational awareness and knowledge of touch points/interdependencies.
  • Demonstrated collaborative skills and ability to work in cross-functional and international environments.
  • Sigma Black Belt, Change Management Certification, PMI Certification.
  • Experience supporting and working with tools and systems used in the Regulatory Affairs environment.
Preferred Experience and Skills:
  • 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.


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 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.

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