Job Description

We invite you to join our mission of advancing the prevention and treatment of diseases. In the capacity of a Global Labeling Lead, you will be instrumental in shaping the labeling strategy and ensuring the development of compliant, high-quality labeling documents to facilitate the safe and effective use of our products worldwide.

This role provides opportunities for professional growth, strategic planning, and allows you to demonstrate your superior execution skills.

Core Responsibilities:

As a Global Labeling Lead, you will guide cross-functional teams in the creation, review, and approval of Core and Local Labeling documents.

You will facilitate Labeling Committees comprised of senior level cross-functional stakeholders and work closely with data owners and subject matter experts regarding scientific and medical information.

You will be responsible for the development and maintenance of Core and US Labeling for assigned products, ensuring compliance with internal and regulatory standards.

You will assist in the development and maintenance of Local Labeling for EU and other countries.

You will propose strategies and labeling language during development or in response to Health Authorities.

You will serve as a subject matter expert, providing advice and guidance on labeling to teams, including labeling precedence and competitor labeling.

As the labeling lead on global Regulatory Affairs sub teams, your input will be essential to our operations.

Qualifications:

Physician, or Master´s degree in nursing (BSN), pharmacy, Physician’s Assistant, or other relevant clinical health related field.

Minimum of 4 years of pharmaceutical label writing experience or relevant regulated industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance, Medical Writing).

Excellent writing and oral communication skills in English.

Proficient project management skills with the ability to handle multiple tasks and prioritize effectively.

Ability to perform well in ambiguous situations.

Proactive and action-oriented approach.

Attention to detail and focus on accuracy.

Skills in influencing and negotiating.

Ability to break down complex scientific & and medical issues and propose solutions.

Effective at leading cross-functional teams with senior leader participation and to drive productive discussions aimed to build alignment on scientific and medical content for assigned products. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Required Skills:

Action-Oriented, Action-Oriented, Adverse Event Report, Compliance Investigations, Detail-Oriented, Employee Training Programs, Labeling Compliance, Management Process, Manufacturing Compliance, Medical Affairs, Mentorship, Multi-Management, Negotiation, Oral Communications, Pharmacokinetics, Pharmacovigilance, Pharmacy, Pharmacy Laws, Policy Implementation, Project Management, Records Retention Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Strategy Development {+ 4 more}

 Preferred Skills:

Job Posting End Date:

07/28/2025

*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:R354751