Director, Regulatory Affairs/Labeling
Location:
, Pennsylvania
Posted:
December 19, 2016
Reference:
LAB000577
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 Quality & Compliance Director, Regulatory Affairs/Labeling:
  • Ensure that global labeling Standard Operating Procedures (SOPs) and Quality Management Plans (QMPs) are in place to support the end-to-end labeling processes and own such SOPs and QMPs, as needed.
  • Prepare tracking of end-to-end labeling process metrics on a regular basis for key labeling milestone dates to ensure compliance with the labeling processes.
  • Oversee tracking of other labeling compliance deliverables such as PLR and PLLR and provide project management support around such deliverables.
  • Present metrics and tracking information to management on a regular basis.
  • Support Health Authority (HA) inspection and audit requests globally, as needed.
  • 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.
  • Oversee labeling staff supporting labeling compliance and quality 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 5 years pharmaceutical/biological experience in a labeling, regulatory or quality function or relevant professional experience.
  • Detail oriented, well organized, and excellent planning skills.
  • Experience working with teams, driving consensus and results.
  • Excellent leadership, communication, interpersonal and collaboration skills.
Preferred Experience and Skills:
  • Experience in labeling and artwork processes and knowledge of regulatory systems 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.

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