Sr. Scientist-Global Labeling Lead

Socket.dev; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits package

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck is seeking a Senior Scientist, Global Labeling Lead to drive core and local labeling strategies for multiple products. You will lead cross-functional teams and ensure compliance with regulatory labeling requirements while supporting timely regulatory submissions.

The role requires strong analytical and communication skills, plus experience guiding labeling across US, EU, and global regions in a fast-paced environment.

Qualifications

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

Responsibilities

• Developing, maintaining, and implementing Core Labeling for assigned products.
• Developing, maintaining, and implementing US Labeling according to regulatory requirements.
• Assisting with Local Labeling (EU and other regions) for assigned products.
• Providing labeling expertise and guidance to teams to ensure regulatory compliance.
• Leading cross-functional teams to develop, review and approve labeling documents.

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

Job Description

We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally.

Senior Scientist, Global Labeling Lead is responsible for:

• developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines
• developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
• assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
• providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements
• serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products
• leading cross-functional teams to develop, review and approve Core and Local Labeling documents
• recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority

Education

• Bachelor's degree in a scientific or medically related discipline required; advanced degree (M.S., Pharm.D., or Ph.D.) preferred.

Required Experience & Skills

• Minimum of 3 years of labeling experience or other relevant pharmaceutical industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, or Pharmacovigilance). An advanced degree with relevant labeling or pharmaceutical industry experience gained during graduate studies may be considered equivalent to the experience requirement.
• Experience leading cross-functional labeling teams, including interactions with senior management, strongly preferred. Demonstrated ability to actively listen, address labeling issues, develop action plans, build consensus, and drive projects to completion.
• Ability to assimilate complex clinical and scientific information, labeling precedents, and competitor labeling, and communicate findings clearly and concisely.
• Understanding of medical concepts and terminology.
• Project management skills with the ability to manage multiple priorities and meet deadlines.
• Proactive problem-solving skills with the ability to make sound recommendations and decisions.
• Ability to work effectively in ambiguous environments and maintain an action-oriented approach.
• Strong written and verbal communication skills.
• High attention to detail and commitment to accuracy.
• Demonstrated ability to influence, negotiate, and collaborate across functions.

Required 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

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$106,200.00 - $167,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R416023