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Job Details

Regulatory Compliance Associate Director - Labeling Artwork Team Lead

Location
Rahway, NJ

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Profile

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its
legacy for over a century
. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the direction of the Director, Worldwide Product Labeling, the Director of Artwork is accountable to:
Develop, co-develop, and oversee process development for all topics related to US artwork (e.g., SOPs, Job Aids, Guidance Documents).
Ensure labeling compliance with all applicable FDA and customs regulations across all labeling components in the Merck portfolio of products and ensuring accuracy against source documents.
Monitor new and updated FDA and customs regulations that are applicable to labeling components; assessing such regulations; and ensuring that they are incorporated into the labeling processes and procedures as well as any other applicable SOPs (e.g., Manufacturing SOPs).
Function as the SME regarding artwork and related compliance requirements including serialization, and provide the strategic perspective from a Merck portfolio perspective.
Function as the Labeling Artwork liaison with manufacturing regarding artwork processes, manufacturing and supply chain requests, and prioritization and escalation of strategic issues and requests.
Manage Labeling Artwork Compliance Team
Qualifications
Education Minimum Requirement:
Bachelor’s Degree is required with a preference of a degree in a scientific or medically related discipline
Master’s Degree is preferred
Required Experience and Skills:
Minimum of 10 years pharmaceutical/biological labeling artwork experience or relevant professional experience.
Regulatory submission and approval experience
Expertise in labeling regulations, and artwork processes
Detail oriented, well organized, and excellent planning and prioritization skills.
Experience leading teams, driving consensus and results.
Excellent leadership, communication, interpersonal and collaboration skills.
Preferred Experience and Skills:
Experience and knowledge of supply chain
AMS Blue, Adobe Acrobat, Microsoft Office, Docu-Proof
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
****
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
#LI-CR1
Job:
Labeling Specifications
Other Locations:
Upper Gwynedd, PA, US
Employee Status:
Regular
Travel:
Yes, 5 % of the Time
Number of Openings:
1
Shift (if applicable):
N/A
Hazardous Materials:
Company Trade Name:
Merck
Nearest Major Market:
New York City
Nearest Secondary Market:
Newark

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