Associate Director CMC Medical Devices/Combination Products/Human Factors job in Kenilworth
|Employer:|| Merck & Co.|
|State:||New Jersey (NJ)|
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.
Reporting to the Executive Director, the Associate Director in Medical Devices and Combination Product CMC is responsible for developing and implementing CMC regulatory strategies for our organization's pipeline products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for all assigned development and lifecycle products. In particular, experience in developing and implementing strategies concerning human factor studies for combination products is required.
Primary responsibilities include, but are not limited to:
• Serve as a Medical Device and Combination Product 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 strategies by ensuring robust assessment of global regulatory Medical Device and Combination Product 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 Medical Device and Combination Product CMC Regulatory Strategy Document for assigned projects.
• Provide regulatory leadership as needed in product in-license/due diligence review.
• Manage execution of Medical Device and Combination Product 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 CMC and Global Regulatory and Clinical Safety 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
• 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, medical devices).
• Demonstrated understanding of human factor studies and regulatory requirements.
• 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.
Education Minimum Requirement: B.S. in a biological science, engineering, or a related field (advanced degree preferred).
• Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry
Required Experience and Skills: At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or medical device field. Experience in assessing products and developing human factor regulatory strategies for combination products.
Preferred Experience and Skills:
• The ideal candidate will have experience in Medical Device and Combination Product CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related medical device /pharmaceutical /biologic operations (e.g., manufacturing, process development, analytical, quality assurance).
• The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events. He/she must have superb collaboration skills, rapid, disciplined decision-making and critical thinking capabilities, and work well under pressure to be successful in this role.
• The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• The candidate must be proficient in English; additional language skills are a plus.
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.
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Visa sponsorship is not available for this position.
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