Global Labeling Lead & Senior Scientist

Merck; North Wales (Montgomery County); Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision insurance (for

401(k) retirement plan

Paid holidays and vacation

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist, Global Labeling Lead to develop and maintain Core Labeling and US/EU labeling for developmental and marketed products, supporting country regulatory labeling.

You will lead cross-functional labeling teams, ensure regulatory compliance, and guide labeling strategy and language to meet global standards while managing multiple priorities in a dynamic environment. Travel up to 10% with a hybrid work arrangement.

Qualifications

• Minimum of 3 years of labeling experience or other relevant pharmaceutical industry experience.
• Experience leading cross-functional labeling teams and communicating with senior management.
• Ability to assimilate complex clinical and scientific information and labeling precedents.

Responsibilities

• Develop, maintain, and implement Core Labeling for assigned products in line with internal standards and guidelines.
• Develop, maintain, and implement US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines.
• Assist with developing and maintaining Local Labeling (EU and most of world) for assigned products.
• Provide labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements.
• Serve as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents meeting quality and regulatory standards for submissions.
• Lead cross-functional teams to develop, review and approve Core and Local Labeling documents.
• Recommend strategies and labeling language for Core or Local Labeling during development or responses to Health Authority.

Skills

Labeling strategy

Regulatory affairs

Cross-functional leadership

Project management

Scientific knowledge

Technical writing

Regulatory submissions

Communication

Detail-oriented

Negotiation

Policy implementation

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 seeks a Senior Scientist, Global Labeling Lead to develop and maintain Core Labeling and US/EU labeling for developmental and marketed products, supporting country regulatory labeling.

You will lead cross-functional labeling teams, ensure regulatory compliance, and guide labeling strategy and language to meet global standards while managing multiple priorities in a dynamic environment. Travel up to 10% with a hybrid work arrangement.