Job Description
Associate Principal Scientist, Regulatory CMC Digital Innovation
Rahway, NJ or West Point, PA
The Associate Director, Regulatory CMC Digital Innovation is a key execution and enablement-focused role reporting to the Executive Director of Regulatory CMC Digital Innovation. The role will focus on developing digital and AI (Artificial Intelligence) innovations and solutions across all aspects of Regulatory CMC workflows. This individual will serve as a subject matter expert (SME) to help Regulatory CMC teams develop, adopt, implement, and maximize digital and AI tools to drive productivity and operational excellence. Additionally, this role will link Regulatory CMC initiatives to GRACS-wide projects and broader Enterprise Digital Initiatives and partnering closely with counterparts (in our Research & Development Division and our Manufacturing Division) to develop and implement integrated solutions.
Responsibilities:
AI-Enabled Authoring & Innovation: Drive the advancement of AI-enabled regulatory authoring capabilities (including Module 2/3 authoring innovations), drafting practical job aids, and continuously identifying novel generative AI drafting opportunities.
Emerging Tech Advocacy: Keep abreast of rapid technological advancements (the latest AI, machine learning, digital tools, etc.) and assessing their utility for Regulatory CMC processes.
Cross-Functional Collaboration: Lead and coordinate cross-functional activities relating to development of AI authoring, process automation, regulatory intelligence, and digital transformation initiatives.
Digital Operating Model Support: Partner in establishing, communicating, and embedding the CMC digital/AI operating model to connect, align, and scale localized AI efforts with broader enterprise digital strategies.
Partner with the Regulatory CMC Systems/Operations group regarding the development of digital solutions impacting our regulatory platforms (e.g., Veeva) as needed.
Application Ownership & Reporting: Serve as the primary Regulatory CMC point of contact for selected key digital tools and platforms (such as the ERA App), and support CMC digital priority tracking and progress reporting.
Research & Development Division-Manufacturing Division Partnerships: Work collaboratively across our Divisions to identify shared digital opportunities, co-develop cross-functional solutions, and ensure smooth data and process handoffs between manufacturing, research, and regulatory.
Advocacy & Change Management: Actively champion enterprise-wide AI adoption by participating in champion networks (e.g., AI Pioneers Champions Network), coordinating feedback loops, and driving change management and training activities.
Mentorship & Community Building: Propose, lead, and mentor digital project teams—including guiding GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement—while fostering collaboration across the broader AI/Digital Enablement community.
Education:
Minimum BS or equivalent Scientific, Technical, or Regulatory degree (focus on chemistry, biology, pharmacy, computer science, or data analytics preferred).
Required Experience:
Minimum of five (5) years of experience in the pharmaceutical or biotech industry, with a strong background in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations.
Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI/LLM solutions in a regulated business setting.
Demonstrated experience delivering enterprise-wide solutions that improve business outcomes.
Experience in technical change management, with a capability to design repeatability assessments, job aids, and training materials for end-users.
Experience mentoring and coaching colleagues or interns on digital projects and technical workflows.
Strong collaboration and communication skills, with a proven ability to work effectively in a matrix environment across various functional units (such as research, manufacturing, and IT).
Strong organizational and project coordination skills, with the ability to manage multiple overlapping initiatives simultaneously.
Up to 10% Travel.
Required Skills:
Change Management, Collaboration, Electronic Common Technical Document (eCTD), Emerging Technologies, Interpersonal Relationships, Liaison Work, Manufacturing Processes, Multitasking, Project Leadership, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Partnerships
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
09/1/2026
*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.
