- 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 ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Merck & Co. (Rahway, NJ)
- …Management Leadership, Product Strategies, Regulatory Affairs Compliance , Regulatory Compliance , Requirements Management, Stakeholder Communications, ... Clinical and Development Digital Solutions (CDDS IT), the Executive Director , Digital Regulatory and Safety, will lead...cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance , and scalability. Act as a… more
- Merck & Co. (Rahway, NJ)
- … product lifecycle management for drug-device combination products.Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the ... Director , Lead of Strategy for Device Product Assessment & Innovation will define and build strategic roadmaps to manage governance, operations, and… more
- Merck & Co. (Rahway, NJ)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our… more
- Merck & Co. (Rahway, NJ)
- …experienceRequired Skills: Audit Readiness, Drug Product Manufacturing, FDA Compliance , FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection ... compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the… 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 ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Merck & Co. (Rahway, NJ)
- …incumbent contributes to product development and marketing strategies to ensure that product value is defined and developed. The Director also works closely ... Job DescriptionUnder the guidance of the Pneumococcal Vaccines Executive Director , Value & Implementation (V&I) Outcomes Research, the incumbent has the primary… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... 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… more
- Merck & Co. (Rahway, NJ)
- …Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing, ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...a state of inspection readiness at all times. The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of an Executive Director , within the Value & Implementation (V&I) Outcomes Research team the incumbent has the following ... to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective… more
- Merck & Co. (Rahway, NJ)
- …for a health authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or ... Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality... concerns.Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie… more
- Merck & Co. (Rahway, NJ)
- …activities-ensuring integration of HF principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- SMBC (New York, NY)
- …**Role Description** **Overview** We are seeking an experienced and strategic **Executive Director ** to lead the **Payables and Receivables** product portfolio ... to deliver scalable, client-centric solutions that meet evolving market and regulatory demands. + Oversee product lifecycle management, including ideation,… more
- SMBC (New York, NY)
- …to facilitate the consistent cross functional delivery of New Business proposals in compliance with regulatory and group guidance. + Engage business leads and ... Manager with responsibility to facilitate the end-to-end delivery of new product and new business activity initiatives. Working closely with stakeholders across… more
- SMBC (New York, NY)
- …to its employees. **Role Description** SMBC Special Credits Group is seeking an Executive Director to lead the Corporate Product Team. This is a key leadership ... initiatives within the group. **Role Objectives: Delivery** Role Responsibilities: The Corporate Product Team Head will be responsible for: . Leading the team with… more
- Merck & Co. (Rahway, NJ)
- …FLEx Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The ... New Jersey and reports to the Systems Process Lead Director at the FLEx Center in the Pharmaceutical Operations...MES system is in a state of control and compliance . Participates in the creation and execution of the… more
