Global Labeling Lead & Senior Scientist – Hybrid

Merck; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid holidays and vacation

Sick days

Job summary

Merck is seeking a Senior Scientist, Global Labeling Lead in Rahway, NJ to drive Core and Local Labeling for developmental and marketed products, collaborating with Regulatory Affairs and cross-functional teams to ensure compliance and timely submissions.

The role emphasizes developing labeling content, guidance to teams, and strategic labeling language across US and EU regions, with a focus on accuracy and regulatory readiness.

Qualifications

• Bachelor's degree in a scientific or medically related discipline required; advanced degree preferred.
• Minimum of 3 years of labeling experience or other relevant pharmaceutical industry experience.
• Experience leading cross-functional labeling teams and coordinating with senior management.

Responsibilities

• Developing, maintaining, and implementing Core Labeling for assigned products.
• Developing US Labeling for assigned products in line with regulatory requirements.
• Assisting with Local Labeling for EU and other regions.
• Providing labeling expertise and guidance to teams and ensuring regulatory compliance.
• Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams.
• Leading cross-functional teams to develop, review and approve Core and Local Labeling documents.
• Recommending labeling strategies and language for Core or Local Labeling during development or regulatory responses.

Skills

Action-Oriented

Adaptability

Adverse Event Report

Communication

Detail-Oriented

Labeling Compliance

Negotiation

Pharmaceutical Product Development

Policy Implementation

Problem Solving

Regulatory Strategy Development

Regulatory Submissions

Scientific Knowledge

Technical Writing

Time Prioritization

Education

Bachelor's degree in a scientific or medically related discipline

M.S., Pharm.D., or Ph.D. preferred

Job description

Merck is seeking a Senior Scientist, Global Labeling Lead in Rahway, NJ to drive Core and Local Labeling for developmental and marketed products, collaborating with Regulatory Affairs and cross-functional teams to ensure compliance and timely submissions.

The role emphasizes developing labeling content, guidance to teams, and strategic labeling language across US and EU regions, with a focus on accuracy and regulatory readiness.