Associate Director, Regulatory Affairs - Labeling Management

Associate Director, Business System Labeling Management

Required experience and skills:

• Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with IT System/Business System Management.

Education Min. Requirement:

BS/BA or an equivalent certification/experience in science, engineering, IT or related discipline with functional working experience in System Development/Management within Manufacturing or Research areas preferred.

Start date: As soon as possible.

:

Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.

Primary area of responsibilities will include:

• Project support for 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.
• Support 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.
• Support 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 proper investigation are conducted, CAPAs 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.
• Provide support and facilitation, as applicable, for the System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested.

Preferred Experience and Skills:

• Candidate must be familiar with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process.
• 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 provides 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.
• Demonstrates strong attention to detail.
• Process-oriented with familiarity of GMP requirements and 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 desirable.
• Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$126,500.00 - $199,100.00

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.

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

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Adaptability, Business Systems, Change Management, Communication, Cross-Cultural Awareness, Data Management, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor Management

Preferred Skills:

Job Posting End Date:
08/16/2025
*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: R358708