Global Labeling Lead — Senior Scientist (Hybrid)

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

Benefits offered by this job

Medical, dental, vision

401(k) and retirement benefits

Paid holidays, vacation, sick days

Job summary

Merck & Co., Inc. in Rahway, NJ, USA, seeks a Senior Scientist, Global Labeling Lead to develop, maintain, and implement Core and Local Labeling for assigned products.

You will lead cross-functional teams to review and approve Core and Local Labeling documents, and provide labeling expertise across Regulatory Affairs sub-teams. The role requires an advanced scientific degree, strong project management, and the ability to work in a fast-paced, highly regulated environment.

Qualifications

• Bachelor's degree in a scientific or medically related discipline required; advanced degree preferred.
• Experience leading cross-functional labeling teams, including interactions with senior management, strongly preferred.
• Demonstrated ability to assimilate complex clinical and scientific information, labeling precedents, and competitor labeling.

Responsibilities

• Developing, maintaining, and implementing Core Labeling for assigned products.
• Leading cross-functional teams to develop, review and approve Core and Local Labeling documents.
• Provide labeling expertise and guidance to teams while ensuring regulatory compliance.

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

Advanced degree (M.S., Pharm.D., or Ph.D.) preferred

Job description

Merck & Co., Inc. in Rahway, NJ, USA, seeks a Senior Scientist, Global Labeling Lead to develop, maintain, and implement Core and Local Labeling for assigned products.

You will lead cross-functional teams to review and approve Core and Local Labeling documents, and provide labeling expertise across Regulatory Affairs sub-teams. The role requires an advanced scientific degree, strong project management, and the ability to work in a fast-paced, highly regulated environment.