Senior Specialist, Compendial/Regulatory Affairs
Location:
West Point , Pennsylvania
Posted:
February 03, 2017
Reference:
REG002760
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.

Compendial Surveillance and Advocacy: Responsible for the review of compendial revisions (proposed and official) as published by the global pharmacopoeia, and facilitating company-wide reviews of these changes. Provides responses to the pharmacopoeia for compendial proposals as needed. Participates in internal teams to enable effective implementation of compendial revisions. Provides new and revised monograph submissions to the pharmacopoeia for Merck products. Establishes and maintains connections with internal and external teams to support compendial surveillance and advocacy with global and national pharmacopoeias. Contributes to special projects as needed to support the overall Compendial Affairs group activities.

Primary Activities:

1. Compendial Review: Reviews global pharmacopoeia publications and websites (USP-NF, Ph. Eur., BP) to determine which compendial changes (proposed and official) to drug products, APIs, excipients, test methods, and general chapters may impact Merck, and ensures that each item is reviewed by appropriate sites and functional areas within Merck. Prepares Compendial Review Memos (summaries) and works in the Compendial Assessment and Implementation Teamsite (CAIT) to communicate and manage compendial reviews. Participates in the Central Triage Team and Targeted Compliance Teams, as appropriate, to ensure visibility to compendial revisions and to help ensure effective implementation planning and compliance with compendial requirements, including new and revised analytical methods and specifications. Based on input from stakeholders, prepares responses to the pharmacopoeia to influence the outcome of compendial proposals, and performs any necessary follow up.

2. Monograph Submissions: Coordinates the submission of new and revised monograph proposals to the pharmacopoeias for Merck APIs and products, extending Merck's initiative for prospective monograph harmonization. Works independently and with internal stakeholders using appropriate systems to collect specifications, methods, validation information and data, then compiles a draft monograph. Works with the Compendial Affairs Director and internal stakeholders to ensure appropriate review prior to submitting the proposal to the pharmacopeia. Partners internally to ensure samples and reference standards are provided to the pharmacopoeia to support the monograph submission. In collaboration with internal stakeholders and the Compendial Affairs Director, responsible for all subsequent follow up correspondence related to the monograph submission.

3. National Pharmacopoeias: Establishes and maintains internal connections (Local Regulatory Affairs, Regional CMC, Central CMC) to enable appropriate surveillance of compendial changes (proposed and official) for priority countries having their own national pharmacopoeia (e.g. Japan, China, Russia, Brazil, Korea, India). Utilizes processes and systems consistent with those used for global pharmacopoeias, as well as processes and systems that may be unique to each country, to manage the compendial review activities. Partners with internal stakeholders and external industry groups to provide responses to proposed compendial changes in these countries, and to advocate on behalf of Merck and the industry with these national pharmacopoeias. May provide new and revised monograph submission to national pharmacopoeias when appropriate, to support Merck's compendial harmonization efforts.

4. External Advocacy: Participates in external advocacy opportunities, including industry groups, pharmacopoeia conferences, project teams and related meetings to address significant compendial issues, supporting Merck positions and enabling benchmarking.

5. Internal Support: Provides compendial guidance and expertise where needed throughout Merck. Responds to questions and issues that arise within Merck regarding any of the pharmacopoeias.

6. Special Projects: Provides support and guidance to other Compendial Affairs staff members, demonstrates and enables continuous improvement, and contributes to compendial special projects, as needed.


Qualifications:
Education:
  • BS or MS in Chemistry, Biology or related science


Required:
  • Minimum of 3 years experience in the pharmaceutical industry
  • Prior laboratory experience or regulatory experience required
  • Demonstrated teamwork skills and project management capabilities
  • Excellent written and verbal communication skills
  • Proficient data management and computer skills


Preferred:
  • Prior laboratory experience, specifically analytical chemistry


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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