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Associate Director, Global Regulatory CMC Biologics

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 is on a quest for cures and is committed to being the world?s premier, most research-intensive biopharmaceutical company. Today, we?re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck?s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products. Be accountable for the delivery of all regulatory milestones through product development.
Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks.
Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed.
Conduct all activities with an unwavering focus on compliance.
Technical Skills:
+ Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
+ Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
+ Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Leadership Skills:
+ Demonstrated ability to generate innovative solutions to complex regulatory 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, interpersonal and negotiating skills.
Education Minimum Requirement: B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.
Required Experience and Skills:
+ At least ten (10) years of relevant experience , including biological research; manufacturing, testing, or licensure of biological products; or related fields. 6 years for Ph.D. degree.
+ The candidate must be proficient in English; additional language skills are a plus.
+ The candidate may be required to travel on a periodic basis.
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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:
EEOC Poster at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
EEOC GINA Supplement? at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of it?s manifestations.
Job _Regulatory Affairs - CMC_
Title: _Associate Director, Global Regulatory CMC Biologics_
Primary Location: NA-US-NJ-Kenilworth
Requisition ID: _REG004025_

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