Director, Regulatory Affairs/Labeling
Location:
, Pennsylvania
Posted:
December 19, 2016
Reference:
LAB000576
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.

Description:

As Labeling Compliance and Quality Leader, Regulatory Affairs/Labeling:
  • Oversee a team of Headquarters and regionally-based staff supporting compliance and quality initiatives and processes globally.
  • Co-own, with the Head of Labeling, the global end-to-end labeling Standard Operating Procedures (SOPs) including compliance and quality processes.
  • Oversee the labeling metrics for the end-to-end global labeling SOPs.
  • Oversee compliance with all applicable global labeling regulations and guidance's working through regional and country contacts, as applicable.
  • Oversee the artwork processes and interactions with supply chain and manufacturing sites.
  • Oversee Health Authority (HA) inspection and audit requests globally, as needed.
  • Assess 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.
  • Support compliance and quality initiatives including CAPA development, tracking and completion.
  • Support global labeling process for device development.
  • Support IT systems to ensure labeling compliance and quality.

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 experience in a labeling, regulatory or quality function or relevant professional experience.
  • Detail oriented, well organized, and excellent planning skills.
  • Experience leading teams, driving consensus and results.
  • Excellent leadership, communication, interpersonal and collaboration skills.

Preferred Experience and Skills:
  • Experience in labeling and artwork processes preferred.
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.

Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

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