Associate Director, Business System Labeling Mgt. - Regulatory Affairs

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.

• 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.

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

• →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.

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

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.