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Senior Specialist, Regulatory Affairs CMC Business Process Support Job West Point United States,  

Posted on : 10 April 2017

Project Description

Senior Specialist, Regulatory Affairs CMC Business Process Support-REG002866DescriptionMerck & 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.QualificationsEducation:- Bachelor s Degree. Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related disciplineRequired:- Minimum 5 years relevant pharmaceutical industryPreferred:- 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 languageOur 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 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.Visa sponsorship is not available for this position.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Regulatory Affairs - CMCJob Title:Sr. Spclst, Regulatory Affairs-CMCPrimary Location: NA-US-PA-West PointOther Locations: NA-US-NJ-RahwayEmployee Status: RegularTravel: Yes, 10 % of the TimeNumber of Openings: 1Shift (if applicable): N/ACompany Trade Name:Merck Nearest Major Market: Philadelphia Job Segment: Business Process, Regulatory Affairs, Law, Engineer, Pharmacy, Management, Legal, Engineering, Healthcare


West Point, PA, US

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