Director, Regulatory Affairs/Labeling
Location:
, Pennsylvania
Posted:
December 19, 2016
Reference:
REG002687
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'll 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:
Education Minimum Requirement:
  • B.S. in a scientifically or medically-related discipline or other relevant degree. Master's degree preferred.
Required Experience and Skills:
  • 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.

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.
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