Executive Director, Clinical Safety and Risk Management Medical Lead for Manufacturing
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.
Under the general direction of the Vice President, Clinical Safety and Risk Management the Executive Director, CSRM Manufacturing Interface Lead will oversee a dedicated Center of Excellence (8-10 physicians and scientists) for providing subject matter expertise for scientific health hazard oversight and medical assessment practices in clinical safety and risk management. Setting departmental strategy and process governance for medical device /combination products and manufacturing safety related issues across the full product portfolio in support of CSRM activities. The incumbent will be accountable for process development, maintenance and execution to ensure compliance with regulatory requirements. The head of this group will lead cross functional collaboration across the enterprise by working closely with CSRM TA leadership, device development, commercial and manufacturing areas to ensure successful execution of our product programs while maintaining regulatory and safety compliance
Primary Responsibilities include:
- Device Safety:
- Sets the safety strategy for interpretation of global regulatory requirements for drug devices and combination products for new product development and maintenance strategies for established products.
- Drives Device Risk Management support via CSRM Device experts in collaboration with RMSTs
- Leads the collaboration with MMD and GRACS Regulatory Device organizations to align on integrated approaches for product safety and quality support.
- Partners with CSRM TA leads to align on integrated approaches for supporting CSRM input into PDTs, Device Development sub-teams, GRTs and RMSTs
- Health Hazard Safety Assessment
- Sets the strategy for the medical assessment of product quality observations / deviations for the Company’s marketed drugs and vaccines.
- The partners with leadership colleagues in MMD Product Quality and Global Safety & Environment during the investigation of product quality complaint reports and GMP non-compliance events to evaluate potential patient safety impact, and provide medical subject matter expertise during Investigative Review, Fact-Finding and Recall meetings.
- Leads a group of physicians and scientists who have specific expertise and responsibility for supporting medical assessment of product quality and device related medical assessments.
- Leads CSRM & MMD collaborations to develop and maintain processes and procedures design to ensure patient safety, quality and compliance
- Represents CSRM leadership on shared governance committees with MMD
Required Skills and Experience:
- M.D. with 7-12 years relevant safety experience.
- Outstanding interpersonal, communication and negotiation skills are required.
- Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies is required.
- Demonstrated leadership attributes; experienced at building and leading high performing cross disciplinary teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
Preferred Skills and Experience:
- 3 - 5 years of specific safety support of manufacturing and/or drug device development or closely related industry experience.
- Expertise in the global regulatory requirements and emerging landscape for Drug Devices and Combination products and GMP for both new product development for initial registration and maintenance of registrations
- Comprehensive understanding of GPV and GMP requirements with a compliance mindset.
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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