Regulatory Business System management Senior Specialist

Job Description

 Organizational Overview: Regulatory Innovation & Information Management (RIIM) is a department within Global Regulatory Affairs & Clinical Safety (GRACS) Operations, Processes, and Systems (O.P.S.) that drives innovation, digital transformation, and operational excellence across regulatory processes. RIIM colleagues play a pivotal role in ensuring the operational integrity, compliance, and strategic alignment of Regulatory systems and AI/Hyperautomation solutions that support the execution of our Research & Development Division Book of Business. 

Within RIIM, the Hyperautomation, AI, and Strategic Innovation Management (HAI-SIM) team enables cutting-edge digital solutions to manage information across GRACS.  HAI-SIM is comprised of three key focus areas: Hyperautomation & AI, Information Management Systems, and Strategic Initiatives and Communications.   

Position Overview: The Senior Specialist Regulatory Affairs position provides tactical support to the Business System Lead or Business System Owner for their capability area within the GRACS Regulatory Innovation & Information Management organization. The role involves project-specific support for System Development, Maintenance, Enhancement and System Monitoring related initiatives including user acceptance testing. Additionally, the Senior Specialist may oversee/participate in end-user support model, system administration, and training resource development activities.

Education:

• Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas experience.

Required Experience & Skills:

• A minimum of 5 years of operations experience, including working on global, large-scale platforms and systems.

• Experience with Veeva Vault, Content Management systems, SharePoint, and Power Platform.

• Experience or background in Business Analysis including skills for gathering and documenting business requirements, creating test plans and test cases, and executing user acceptance testing.

• Experience in supporting system users via training and creation of training documentation (user guides, quick reference cards, online training) and addressing user issues through business administrative tasks

• Strong project management and IT technical skills.

• Strong negotiating and consensus building abilities.

• Proven ability to complete projects and achieve results in an ambiguous work environment.

• Preferred experience working with vendor, supplier, sub-contractor relationships.

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

• Strong interpersonal skills to achieve well-communicated expectations.

• 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 presentation development, delivery and online meeting tool skills.

Required Skills:

Accountability, Accountability, Adaptability, Audits Compliance, Business Analysis, Content Management Systems (CMS), Cross-Cultural Collaboration, Detail-Oriented, Digital Transformation, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Innovation Management, Mentorship, Online Trainings, Operational Excellence, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

03/15/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.