- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving… more
- Merck & Co. (Rahway, NJ)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}Preferred Skills: Current ... science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- …Name Development, Process Improvements, Professional Presentation, Project Management, Regulatory Compliance , Strategic PlanningPreferred Skills: Current ... the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are...for these launches, we are looking for an Associate Director (AD) to join our center of excellence.Description:-Under the… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- … compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the ... improvement experienceRequired Skills: Audit Readiness, Drug Product Manufacturing, FDA Compliance , FDA GMP, FDA Inspections, FDA Regulatory Requirements,… more
- Merck & Co. (Rahway, NJ)
- …Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management, Stakeholder ManagementPreferred Skills: ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...of the Value Chain Management Team, guiding strategy, ensuring compliance , and enabling manufacturing excellence from development through commercialization.… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- …Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs ... development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and design… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …are currently seeking a Cardiovascular & Respiratory Competitive Intelligence Director specializing in PAH, COPD, and other cardiopulmonary diseases. This ... comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technologyDeveloping a global internal network of… more
- Principal Financial Group (New York, NY)
- **What You'll Do** The Director , Funds Operational Risk will serve as a key risk partner to Principal Asset Management's US funds platforms-covering mutual funds, ... operations, shareholder services, fund accounting, and related in-house functions. The Director will partner closely with business and functional leaders to embed… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …mission?at MSK and around the globe. **Exciting Opportunity at MSK:** Associate Director , Respiratory Therapy & Pulmonary Function At Memorial Sloan Kettering Cancer ... and innovation. We are seeking an accomplished and forward-thinking Associate Director of Respiratory Therapy & Pulmonary Function to provide operational, clinical,… more
- SMBC (New York, NY)
- …Description** **Overview** We are seeking an experienced and strategic **Executive Director ** to lead the **Payables and Receivables** product portfolio within our ... collaboration with cross-functional teams including Technology, Operations, Sales, Corporate Banking, Compliance , and Finance. This position reports to the Head of… more
- SMBC (New York, NY)
- …a business from the ground up, design and implement a robust legal and regulatory compliance framework in partnership with Compliance colleagues, and educate ... base (ranging from junior staff to senior management) on the US regulatory requirements for investment advisers. **Role Objectives** + Provide legal, regulatory… more
