Director, Regulatory Affairs/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.
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As Labeling Writer/Director, Regulatory Affairs/Labeling:
Co-own, with the Therapeutic Area Lead, the global labeling strategy for programs/products (e.g., new products, programs with multiple different indications). Ensure strategic alignment and consistency across the labeling for assigned portfolio of products.
Accountable for labeling deliverables for specific product assignments and management of labeling staff with responsibility for preparation of labeling for new products for inclusion with Worldwide Marketing Applications, and revised labeling for marketed products; presentation of proposed labeling to the Merck Labeling Committees for review and approval; and preparation of labeling for submission to Health Authorities and/or subsidiaries worldwide.
Determine timelines for labeling deliverables for regulatory filings, approvals and compliance activities for assigned team, and ensure that such timelines are met.
Chair Merck Labeling Committee meetings to ensure that labeling is strategically aligned with and represents the labeling vision for the product including key labeling statements; global market positioning; and Merck corporate values, beliefs and position.
Present labeling strategy to Merck Development and Regulatory Teams.
Interact with country-level Regulatory Affairs staff on key strategic labeling and regulatory issues. These interactions include management of the review of local country labeling by the Labeling Committees.
Assessment of new regulatory guidance’s and regulations as well as implementation of such guidance’s and regulations into the global labeling processes.
Lead labeling process improvement initiatives.Qualifications
- B.S. in a scientifically or medically-related discipline or other relevant degree.
- Master's degree preferred.
Required Experience :
- Minimum of 10 years pharmaceutical/biological labeling experience or relevant professional experience. Regulatory submission experience.
- Expertise in labeling regulations.
- Detail oriented, well organized, and excellent planning skills.
- Experience leading teams, driving consensus and results.
- Excellent leadership, communication, interpersonal and collaboration skills.
- Adobe Acrobat, Microsoft Office.
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