EU Labeling Senior Specialist (P3)

Job Description

**This role can be done remotely from home in any of the 4 countries with travel to the office on average once per month**

EU Labeling Senior Specialist

Job Description

General Summary

The purpose of Global Labeling is to drive labeling strategy and ensure high quality and compliant labeling documents which ensures the safe and effective use of products for patients and healthcare providers, globally. As part of Global Labeling, and under the supervision of the EU Labeling Lead, the EU Labeling Senior Specialist is responsible for the labeling of developmental and marketed products registered under EU procedures (MRP/DCP/CP).This includes collaboration with the cross-functional labeling team to develop and maintain the EU Product Information (including all its Annexes as defined by EU legislation).

Responsibilities of the EU Labeling Sr Specialist may include, but are not limited to:

• Proofs, edits, and manages labeling documents.
• Updates designated databases/internal sites containing department information according to standard operating procedures (SOPs).
• Monitors mailboxes and handles inquiries, as appropriate.
• Uses experience and knowledge to create and update labeling and labeling documentation.
• Participates in programs for continuous improvements of labeling activities and business requirements.
• Supports Corrective and Preventative Actions (CAPAs).
• Stays apprised of EU regulations.
• Initial decision making, under guidance.
• Owns decisions related to editorial changes.
• Works internally with the Regional Labeling team, the Regulatory Affairs Europe Liaison and internal stakeholders.
• Works cross functionally to ensure timely regulatory submissions, high quality and compliant EU labeling documents and to support business objectives.
• Interacts with key business partners

Skills

• EU labeling experience in oncology or vaccines or other relevant industry experience related to developing regulatory documentation.
• Regulatory submission experience.
• Knowledgeable about the scientific principles of the drug development process.
• Process improvement and compliance/quality experience.
• Ability to develop relationships and work well with others in demanding situations with a positive attitude.
• Excellent attention to detail, well organized, high project management skills.
• Experience facilitating meetings and driving consensus and results.
• Good leadership, communication (verbal and writing).
• Proven ability in medical/technical writing.
• Effective critical thinking and problem-solving skills
• Experience in Word, Excel and PowerPoint, and document management tools.

Education

• Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.
• Minimum of 4 years of pharmaceutical experience or relevant professional experience

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Skills

• EU labeling experience in oncology or vaccines or other relevant industry experience related to developing regulatory documentation.
• Regulatory submission experience.
• Knowledgeable about the scientific principles of the drug development process.
• Process improvement and compliance/quality experience.
• Ability to develop relationships and work well with others in demanding situations with a positive attitude.
• Excellent attention to detail, well organized, high project management skills.
• Experience facilitating meetings and driving consensus and results.
• Good leadership, communication (verbal and writing).
• Proven ability in medical/technical writing.
• Effective critical thinking and problem-solving skills
• Experience in Word, Excel and PowerPoint, and document management tools.

Education

• Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.
• Minimum of 4 years of pharmaceutical experience or relevant professional experience.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R232021