Regulatory Innovation

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 the 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 supports project coordination, project management, change management, and communications for the AI/Hyperautomation solutions team. This role is critical in coordinating program activities and producing high-impact communications and presentations for diverse audiences across the organization.

Key Responsibilities:

• Project Coordination & Project Management:

• • Support change management efforts by developing communication materials to engage stakeholders and build awareness around the AI solutions being delivered.

  • Schedule and coordinate meetings, ensuring agendas, materials and logistics are prepared; follow up on action items and manage decisions across teams.

  • Create executive-ready slide decks that clearly communicate AI solution progress, value, and impact.

  • Track engagement metrics (e.g., site traffic, forum participation, feedback engagement) to assess communication effectiveness.

  • Facilitate tool transition planning post-deployment, including defining ownership expectations and updating RIIM tracking documentation.

• Communications & Storytelling

• • Design visually engaging slide decks and communication materials for cross-functional audiences.

  • Maintain a content dashboard for AI/Hyperautomation communications, tracking milestones, releases, and messaging.

  • Draft and distribute clear, consistent communications about project milestones, timelines and key decisions (e.g., emails, newsletters).

• Digital Content Creation & Platform Management

• • Maintain and enhance the AI/Hyperautomation sites, ensuring content is current, accessible, and aligned with branding guidelines.

Education:

•   Bachelor's Degree plus 3-5 years pharmaceutical regulatory experience

  ·       Preferred 5+ years Project Management, Change Management, and/or Communications related experience.  

• Artificial Intelligence (AI) experience preferred

​Experience and Skills

• Effective Communication: High level of proficiency in English, strong written and verbal skills in English; able to convey ideas clearly and professionally across diverse audiences

• Project Management: Proven ability to coordinate cross-functional projects and engage stakeholders in regulatory and digital transformation initiatives.

• Collaboration: Effective team player with strong interpersonal skills across meetings, emails, and in-person interactions

• Digital Fluency: Proficient in Microsoft 365 tools (Teams, SharePoint, PowerPoint, Word, Excel), Copilot, and Power Platform; quick to adopt new technologies. AI experience preferred

• Organization & Time Management: Skilled at managing multiple priorities and deadlines with efficiency and flexibility

• Adaptability: Comfortable navigating changes in tools, processes, and team dynamics

• Problem Solving: Proactive in identifying and resolving challenges independently.

• Creativity: Capable of generating innovative ideas and engaging content tailored to target audiences.

Required Skills:

Adaptability, Audits Compliance, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

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:

11/17/2025

*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.

Requisition ID:R371937

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