North Wales, Pennsylvania

Job Description

Position Purpose 

Reporting to the Director of R&D Business Systems Regulatory, Health Registration Management (HRM), the Associate Director of Regulatory Business Systems Oversight, HRM, is accountable for providing operations of business systems established for Regulatory. This role is accountable for ensuring regulatory systems are fully supporting all phases of product registration and lifecycle management for our company's products. This role drives strategic activities for regulatory business system capabilities in an alignment with the Executive Director of R&D Business Systems Regulatory. This role collaborates with the many stakeholders and users of the regulatory capabilities to plan and execute the operational business system activities. 

Organizational Relationships 

  • Resources Managed (budget and FTEs) 

Organization Scope 

Primary Responsibilities 

The Associate Director of Regulatory Business System Oversight, Health Registration Management (HRM) is accountable and responsible for the following activities: 

  • Operates the business system capabilities of the regulatory organization focused on registration management, partnering with external parties and other internal R&D functions where appropriate. 

  • Leads projects and initiatives supporting the long-term vision and strategy for regulatory business systems, helping to drive business outcomes. 

  • Provides industry expertise and practical knowledge of current and emerging technologies and processes approaches within regulatory, including, but not limited to, registration, dossier publishing, and product lifecycle management. 

  • Influences leaders to see new opportunities for enhanced regulatory business system capabilities. 

  • Proactively identifies new capabilities and enhancements that will improve regulatory and broader R&D operations. 

  • Functions as a contributing member of initiative teams  which represents the strategic operations organization at both internal and external forums on regulatory business system capabilities for product registration and publishing as a representative of HRM 

  • Investigate, analyze and document user requirements, including but not limited to requirements definition, solution design, configuration and administration plan. 

  • Support system validation activities such as producing user acceptance/performance qualification testing scripts and executing the test scripts. 

  • Ensure high ethical standards and a culture that values honesty, integrity, and transparency. 

Qualification, Skills & Experience 
  • Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas is required 

  • 5+ years of leading regulatory business system capabilities within a research and development organization 

  • 3+ years of experience in a regulated research and development environment, preferably in the regulatory affairs product registration and lifecycle management domain 

  • Must have proven track record to be able to think critically, strategically, independently and problem solve 

  • Must have high level of motivation, drive, and demonstration of our company's leadership values 

  • Excellent written and verbal communication skills including ability to write clearly and concisely 

  • Top notch interpersonal skills in difficult situations 

  • Driver of change and innovation 

  • Ability to work seamlessly with all levels of personnel 

  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations 

  • Excellent SharePoint and Excel skills 

#Newco

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work, Telecommuting

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R81476

North Wales, Pennsylvania

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.