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Associate Director, Pharm Pre - Approval CMC

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.
The primary activities include and are not limited to the following:
+ Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.
+ Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
+ Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.
+ Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.
+ 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 GRACS CMC management, as needed
+ Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of Merck pharmaceutical products worldwide.
+ Conduct all activities with an unwavering focus on compliance
Education Minimum Requirement:
+ B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry
Required Experience and Skills:
+ At least 3-5 years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
+ The candidate must be proficient in English; additional language skills are a plus.
Preferred Experience and 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.
+ 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.
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.
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EEOC GINA Supplement? at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of it?s manifestations.
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Job _Regulatory Affairs - CMC_
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Other Locations: _NA-US-PA-West Point_
_Title:_ _Associate Director, Pharm Pre - Approval CMC_
_Primary Location:_ _NA-US-NJ-Rahway_
_Requisition ID:_ _REG003949_


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