MSD

Associate Director, Health Registration Management Business Process

CRI - San Jose - San Jose (City Place) Full time

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world.

Join our team and help us drive change and innovation in Health Registration Management (HRM).

Responsibilities

This role reports in a matrix structure to the current Functional Area Collaboration Team (FACT) Leads and is responsible for ensuring clear, concise communication on all content that impacts key business areas. The Associate Director will support FACT Leads and Teams with meeting coordination, note-taking, managing the Bright Ideas intake process, and handling all follow‑ups. Building strong partnerships with SMEs and other functional area partners is essential to ensure business continuity and foster innovation.

The ideal candidate will have a strong understanding of headquarters‑driven approaches to operational maintenance and change requests—along with how these impact global regions. Hands‑on system experience with Veeva and a solid understanding of the Veeva Registration technology platform, its roadmap, and its role in supporting process areas are required.

This role also plays a key part in training, supporting the Training Operations Lead. When appropriate, the Associate Director will lead efforts to strengthen continuity and collaboration with multi‑phase Veeva Vault training teams. They will manage the tactical training needs tied to multiple Veeva Registration Platform releases throughout the year. Prior experience developing training materials for large, cross‑functional rollouts is preferred, as is experience partnering with broader Learning and Development teams for deployment. This role will also work within the Veeva Security matrix to support training, access, and administrative tasks. Excellent communication skills, regulatory knowledge, and an exceptional attention to detail are essential.

The Associate Director will serve as the main point of contact for Health Registration Management audit and inspection requests worldwide. Experience in triaging and prioritizing requests with urgency is required.

Additionally, this role will support aspects of the Health Registration Change Control Board (CCB). Responsibilities include helping manage and optimize processes to maintain agile and compliant change control procedures in partnership with Veeva/IT AMS TOPS Teams/HRM Model and Veeva cross‑vault governance. The Associate Director will ensure change controls are reviewed, aligned, and guided from concept through implementation in collaboration with key stakeholders, SMEs, and IT groups. Experience leading cross‑functional teams and ensuring alignment between business operations and system operations is essential to maintain process integrity, technology enablement, and innovation.

 

Qualifications

  • Strong understanding of headquarters-based approaches towards operational maintenance and change requests.

  • Strong technical background and skills, especially with Veeva Registration platform

  • Proven experience with Microsoft and Microsoft SharePoint

  • Experience in developing training materials for large organizational cross-functional training rollouts.

  • Strong understanding of business processes

  • Excellent communication skills, regulatory knowledge, and attention to detail.

  • Experience in triaging and prioritizing requests with a sense of urgency.

  • Strong interpersonal and collaboration skills

  • Ability to work independently to deliver team objectives

  • Proficiency in MS Office products (Word, Excel, PowerPoint, SharePoint, Teams)

  • Advanced English proficiency

  • Minimum 8 years of pharma industry experience, with at least 5 years in a regulatory/compliance area using records and/or document management systems.

Education

Bachelor’s degree in a business, scientific, or operational discipline relevant to life sciences

Required Skills:

Accountability, Accountability, Adaptability, Business Continuity, Business Operations, Business Processes, Business Process Management (BPM), Change Management, Communication, Cross-Cultural Awareness, Data Management, Documentations, Employee Training Programs, FDA Regulations, IT M&A, Maintenance Planning, Mentorship, Operation Maintenance, Pharmacovigilance, Policy Implementation, Prioritization, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions {+ 5 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/20/2026

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