- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Merck & Co. (Rahway, NJ)
- …technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages scientific/technical experience to develop ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... technical content of assembly process FMEAs to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient… more
- Eisai, Inc (Nutley, NJ)
- …Influence, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Legal Knowledge, ... price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management… more
- Merck & Co. (Rahway, NJ)
- …commercializing and supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global ... functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team (LT). This role… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related ... company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain...develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP system… more
- Merck & Co. (Rahway, NJ)
- …Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management, and compliance in vendor agreements. Ability to work ... procurement policies, procedures, and governance frameworks to ensure consistency, compliance , and cost discipline. Collaborate with finance, legal, R&D, and… more
- Merck & Co. (Durham, NC)
- …Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk -based approach ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Merck & Co. (Rahway, NJ)
- …development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, ... network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings.… more
- Repligen (Waltham, MA)
- …internal and external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across the organization and ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO… more
- USAA (Phoenix, AZ)
- …witness statements) determine liability and analyze information obtained to establish compliance for regulatory requirements and settlement value. Evaluate and ... effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: High School Diploma… more
- Macquarie (New York, NY)
- … Assurance team, where you will play a critical role in ensuring compliance with regulatory requirements and internal policies. Our collaborative environment ... In this role, you will design and implement comprehensive compliance testing reviews to ensure adherence to regulatory...and anticipate the risks of tomorrow. Our divisions include compliance , credit, financial crime risk , internal audit,… more
- USAA (Colorado Springs, CO)
- …confirm/analyze coverage, recognize liability exposure and negotiate equitable settlement in compliance with all state regulatory requirements. You will ... to facilitate moderate complexity claims resolution. May also involve external regulatory coordination to ensure appropriate documentation and compliance .… more
