Associate Director - Business System Labeling Management, Regulatory Affairs

Job Description

Summary:

Join the GRACS Regulatory Innovation & Information Management organization as Associate Director, Business System Labeling Management, and help shape how Global Labeling works with the systems that power it. This is a team-first environment where collaboration across functions, regions, and time zones is part of everyday work, and where leaders succeed by bringing others along. Continuous learning is expected and supported. Our systems, processes, and regulatory landscape keep evolving, and so do we. You will bring the technical aptitude to own GxP business systems from requirements through release and hyper care, and the judgment to turn complex business needs into clear direction for Business Analysts, IT partners, and users. Above all, we are looking for someone with a “how can we” attitude, who meets competing priorities and tight timelines by finding the path forward rather than the reason to stop.

Required experience and skills:

• Requires 10+ years of experience in Pharmaceutical Regulatory Affairs Operations, including demonstrated end-to-end ownership and management of GxP business systems (system lifecycle, release management, change control, and operational support), with applied knowledge of SDLC. Labeling Process and Systems Digital Enablement experience strongly preferred.

Education Min. Requirement:

• BS/BA in science, engineering, IT or related discipline with functional working experience in System Development/Management within GxP regulated areas preferred.

Responsibilities:

• Manage and lead Business Analysts for complex data analytics application.
• Lead System Development, Maintenance, Enhancement and System Monitoring related initiatives.
• Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs.
• Facilitate System Operations Mtgs including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities.
• Lead the development of User facing System Resources ensuring supporting materials remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources.
• Lead System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases.
• Facilitate and oversee the System Support Model for systems within remit including:
  • Monitor user support cases, ensuring thorough root cause investigations are conducted, CAPAs are detailed and closed effectively, and communication is consistently done to reduce instances of recurrence.
  • Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users.
• Conduct System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally.
• Facilitate System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested. 

Required Experience and Skills:

• Candidate must be proficient with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process.
• Must have experience with audit/inspection facing support for GxP systems and ability to communicate complex concepts in high pressure situations.
• Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.
• Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information. 
• Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships.
• Effective communication skills (verbal and written). 
• Ability to work cooperatively with others and provide significant contributions as a member of a team in addition to serving in a leadership capacity.
• Strong organizational skills. 
• The ability to be flexible and handle multiple tasks well, under pressure that span Global Time zones.
• Demonstrates strong attention to detail.
• Process-oriented and proficient with GxP (GMP) requirements with experience working in a highly regulated industry.
• Experience with business process mapping and system design for workflow management is an asset.
• Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is required.
• Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications.

Required Skills:

Audit Readiness, Business Requirements Management, Business Systems Management, GxP Regulations, Regulatory Affairs Management, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, System Development Life Cycle (SDLC) Documentation, Systems Development Lifecycle (SDLC)

Preferred Skills:

Business Analysis, Change Control Management, Process Improvement Initiatives, Root Cause Analysis (RCA), Technical Documentation Management

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is:

USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$129,000.00 - $203,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

11/25/2026

*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.