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Senior Regulatory Specialist Global Regulatory Affairs and Clinical Safety: Vaccines CMC

Merck


Location:
West Point, PA
Date:
07/20/2017
2017-07-202017-08-19
Job Code:
REG002983
Merck
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Job Details

Job Title: Senior Regulatory Specialist Global Regulatory Affairs and Clinical Safety: Vaccines CMC  - REG002983

Description
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time. 

Reporting to the Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for Merck's vaccine products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Primary responsibilities include, but are not limited to:

Regulatory Responsibilities:
  • The CMC Product Lead is accountable for the delivery of all regulatory milestones for less complex products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. 
  • Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects.
  • Lead execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. 
  • Conduct all activities with an unwavering focus on compliance.

Technical Skills:
  • Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. 
  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. 
  • Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance). 

Leadership Skills:
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. 
  • Demonstrated effective leadership, communication, and interpersonal skills. 



Qualifications
Education: 
  • B.S. in a biological science, engineering, or a related field. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.

Required: 
  • At least two (2) years of relevant experience with an advanced degree, including biological/pharmaceutical research; manufacturing, testing, or licensure of vaccine or biological products.
  • Must be proficient in English

Preferred:
  • Advanced degree in a biological science, engineering, or a related field. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.
  • At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or licensure of vaccine or biological products.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 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:
 
           
           


Job Regulatory Affairs - CMC

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 8

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