Senior Specialist, Worldwide Product Labeling
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the supervision of Director, Worldwide Product Labeling, labeling writer is responsible for managing labeling for new products and marketed products globally. This includes collaboration with the cross-functional labeling team to develop and maintain the Company Core Data Sheets (CCDS), US, EU and rest of world labeling, including associated patient labeling documents. Responsibilities may include, but are not limited to:
- Collect and review information pertinent to the safety and efficacy of assigned marketed and new products.
- Prepare and circulate labeling proposals for approval through Merck’s cross-functional labeling committee.
- Present proposed labeling to Merck’s cross-functional labeling committee for review and approval.
- Provide strategic labeling guidance to Merck’s cross-functional labeling committee including staying up-to-date with labeling guidances and regulations worldwide.
- Coordinate and participate in preparation of submission-ready labeling documents.
- Provide project management support throughout the labeling process to ensure documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
- Ensure all actions taken within role follow applicable SOPs and regulations so that high quality and compliant labeling documents are maintained.
- Manage and provide guidance to other labeling writers as needed.
- Develop/revise labeling specific SOPs.
- 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.
- Experience leading teams, driving consensus and results.
- Excellent leadership, communication (verbal and writing) and collaboration skills.
- Labeling experience (company core data sheet, US , EU) in oncology or vaccines or other industry experience in oncology or vaccines preferred.
- Proven ability in medical writing.
- Regulatory submission experience.
- Process improvement and compliance/quality experience.
- Detail oriented, well organized, high project management skills.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Labeling Specifications
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck