Job Description

We invite you to join our mission of advancing the prevention and treatment of diseases. In the capacity of an Labeling Scientist, 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 that are registered under EU procedures (MRP/DCP/CP).

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

Core Responsibilities:

You will guide cross-functional teams in the creation, review, and approval of EU 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 EU Labeling for assigned products, ensuring compliance with internal and regulatory standards.You will serve as a subject matter expert, providing advice and guidance on labeling to teams, including labeling precedence and competitor labeling.You will propose strategies and labeling language during development or in response to Health Authorities.

Qualifications:

Bachelor’s degree in a scientific or medically-related discipline required.  Master’s degree preferred.Minimum of 2 years of labeling experience or relevant regulated industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance, Medical Writing).Excellent writing and 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 issues and propose solutions.

What we offer: 

Exciting work in a great team, global projects, international environment Opportunity to learn and grow professionally within the company globally Hybrid working model, flexible role pattern (e.g., even 80% full-time is possible in justified cases) Pension and health insurance contributionsInternal reward system plus referral program5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card Vodafone, Raiffeisen Bank, Foodora, and Mall.cz discount programs Up-to-date laptop and iPhone Parking in the garageCompetitive salary, incentive pay, and many more 

 

Ready to take up the challenge? Apply now! 
Know anybody who might be interested? Refer this job!

 

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Clinical Judgment, Clinical Judgment, Communication, Compliance Assurance, Compliance Program Development, Compliance Remediation, Data Quality Assurance, Detail-Oriented, Manufacturing Compliance, Medical Affairs, Medical Writing, Multi-Management, Persuasion, Pharmacokinetics, Pharmacotherapy, Pharmacovigilance, Policy Implementation, Prioritization, Project Management, Promotional Review, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation, Regulatory Labeling, Regulatory Reporting {+ 5 more}

 Preferred Skills:

Job Posting End Date:

06/23/2025

*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:R351924