Global Labeling Operations Specialist

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 instructions for the safe and effective use of products for patients and healthcare providers globally.

As part of the Labeling Operational Excellence function in Global Labeling, the Global Labeling Operations Specialist (GLOS) is responsible for:

• Serving as the primary labeling operations point of contact for Global, US, and EU Labeling Leads

• Receiving, reviewing, and processing labeling operational tasks for Core, US and EU labeling update requests on schedule, ensuring timely resolution of any issues throughout the update cycle while ensuring all labeling deliverables meet regulatory standards and timelines with consistent, high-quality execution

• Performing labeling operational tasks (quality checks, verifications, proofreading, creation of labeling documents, including US SPL, and updating trackers)

• Providing effective functional oversight in situations where a vendor performs labeling operational tasks

• Collaborating with cross-functional teams to prioritize and manage labeling operational support for labeling updates, which may include product launches

• Being Subject Matter Experts (SMEs) for labeling operational tasks and relevant business processes, systems, and documentation, including supporting process documentation updates

• Monitoring and compiling competitor labeling for strategy development and decision‑making to Global, US and EU Labeling Leads

Requirements:

• Education: · Required: Bachelor’s degree in Science, Health related fields or in Communications.

• Proven advanced / bilingual level of English.

• Experience & Skills: At least 2 years’ experience in Regulatory Affairs in the pharmaceutical industry, labelling experiences preffered.

• It will be a plus to have experience in operational roles or project management.

• Excellent communication and organizational skills, with a proven ability to simultaneously balance diverse activities for several projects.

• Good interpersonal skills.

• Excellent attention to detail and quality-oriented

Required Skills:

Accountability, Accountability, Business Due Diligence, Business Operations, Business Processes, Competitive Strategies, Compliance Investigations, Compliance Program Development, Customer Experience Management, Data Quality Assurance, Detail-Oriented, Disease Prevention, IT Demand Management, Labeling Systems, Leadership, Manufacturing Compliance, Medical Writing, Motivational Leadership, Pharmaceutical Labels, Policy Implementation, Preventive Action, Prioritization, Promotional Review, Proofreading, Regulatory Affairs Management {+ 3 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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

Job Posting End Date:

06/21/2026

*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.