Senior Specialist, Pharmaceutical Labeling Artwork

Merck & Co. • Rahway, NJ

443d • $111,400 - $175,300 • Onsite

About The Position

The Senior Specialist role serves as a Labeling Artwork Lead within the US Market Artwork Team, responsible for developing and revising artwork for regulatory submissions and production needs. This position involves coordinating the end-to-end artwork development process, ensuring compliance with FDA and WHO regulations, and collaborating with cross-functional teams to support product launches and complex artwork execution.

Requirements

• Bachelor's Degree is required.
• Minimum of 4 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 communication, interpersonal and collaboration skills.

Nice To Haves

• Experience and knowledge of supply chain.
• Medical Device & Combination Product Labeling.
• Adobe Creative Suite and Microsoft Office proficiency.
• Experience with Perigord and Docu-Proof.

Responsibilities

• Develop and revise artwork for US market for NDA/BLA submissions and supplements to FDA.
• Revise artwork for WHO submission and production.
• Initiate artwork projects in Artwork Management System and review and approve composed artwork.
• Coordinate the end-to-end US artwork development process for labeling.
• Work cross-functionally with CMC and manufacturing sites to implement new or revised labeling.
• Support Artwork in product launches and unique or complex artwork execution.
• Work with a cross-functional team to enable artwork reviews and drive consensus.
• Participate in creation of FDA response documents and meetings when necessary.
• Provide labeling components for NDA/BLA Annual Reports.
• Participate in special project assignments related to artwork and related labeling when needed.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree