Senior Specialist, Regulatory Affairs CMC Business Process Support Job - United States
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.
Individual Contributor, under the broad guidance of the Director/Associate Director Regulatory Affairs, will be responsible for evaluation of CMC information within Regulatory databases and Manufacturing Change Control databases. The position will be responsible to review Change Control Business Processes and regulatory systems / documentation to generate Regulatory Reports for CMC Conformance group and make recommendations for further actions. The candidate’s primary responsibilities will be focused on integration and standardization of CMC business processes for manufacturing change control covering commercial product introductions and life cycle management. The incumbent will collaborate with key system stakeholders and peers to align on CMC functional requirements for business process improvement initiatives including user requirements, documentation, and training materials. The position will be responsible to deliver consistent CMC Business Processes that meet the organizational and operational needs of the CMC team including increase conformance, efficiency, and user experience. The incumbent will participates in cross divisional/cross team working groups to promote harmonization and improve platforms for digital data management.
- Bachelor’s Degree. Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline
- Minimum 5 years relevant pharmaceutical industry
- Minimum 3 years’ experience with change control and/or deviations management (demonstrated Complex problem solving),
- Team lead/facilitator, knowledge of regulations related to CMC
- Superior written/oral communication
- Fluent in English language
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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Regulatory Affairs - CMC
Job Title:Sr. Spclst, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Business Process, Regulatory Affairs, Law, Engineer, Pharmacy, Management, Legal, Engineering, Healthcare