- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key markets (Required)2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of...associated CAPAs or process deviations, and coordinating the end-to-end management of these. They will also be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery of laboratory data in ... processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize… more
- Eisai, Inc (Raleigh, NC)
- …profile, we want to hear from you. The Director Western Supply Chain Management (SCM) Unit is accountable and/or responsible for providing an uninterrupted supply of ... Products distributed both domestically and globally. The team is also responsible for management of CMOs where the contractual relationship is with ESI or ECL… more
- Merck & Co. (Rahway, NJ)
- …Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management , Regulatory Reporting , Regulatory Training, SAP ... SAP GTS or Integration Point, or similar databases, very desirableStrong project management skills and ability to conduct complex reporting processesSustained… more
- Merck & Co. (Rahway, NJ)
- …Improvements, Project Management , Project Risk Assessments, Regulatory Affairs Management , Regulatory Reporting , Regulatory Training, SAP Global ... on the use of certain special tariff provisions for US imports;Interface with global regulatory and others on issues involving FDA, USDA, and other health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues , ECP keeps us accountable every step of the ... and implement technology and data analytics solutions that enhance compliance monitoring, reporting , and risk management Utilize data analytics to identify… more
- Merck & Co. (Rahway, NJ)
- …and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global efforts of teams in other regions. May directly manage complex safety issues related to individual case review, risk management , translational medical ... findings are incorporated into comprehensive safety reports as required by all regulatory authorities.Ensure a robust risk management process with appropriate… more
- Merck & Co. (Rahway, NJ)
- …SAP GTS or Integration Point, or similar databases, very desirableStrong project management skills and ability to conduct complex reporting processesSustained ... as well as handling other trade related question and issues , on an as needed basis. The position is...Marketing Compliance, Project Leadership, Project Management , Project Management Information Systems (PMIS), Regulatory Communications {+… more
- Eisai, Inc (Nutley, NJ)
- …ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers ... different phases.The VP of Global Clinical Operations is responsible for the management , oversight, and direction of the clinical operations function in the… more
- Merck & Co. (Durham, NC)
- …the team through actions, coaching, and prioritization - Coach individuals when reporting safety issues and completing corrective/preventative actions - Drive ... employee development, routine 1:1 meetings and coaching, recognition, and performance management ). Additionally, they must become proficient in the use of… more
- Eisai, Inc (NJ)
- …TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and training on the ... activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. The… more
- Aequor (Thousand Oaks, CA)
- …to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies. Reporting on team and plant metrics to ensure ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation ... timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to customers o Provides regular updates for Brand Teams and Senior Management on contract performance issues , including over- and under-performing contracts ... Committee, offer development, contract development, negotiation, pre-deal forecasting and reporting of contract profitability of customer segments for all Novo… more
- Merck & Co. (Durham, NC)
- …ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist ... Issue Resolution (with appropriate escalation as required). Resolve Technical Issues (Investigations, CAPAs, Process Improvements, Source Changes, Technical Transfers,… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... assist in troubleshooting upstream and downstream process, product, and equipment issues and deviations. Provide timely reporting , investigation, and resolution… more
- Aequor (Tampa, FL)
- … issues , problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible. Stop work where deemed necessary to ... and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples. Perform… more
- Aequor (Thousand Oaks, CA)
- …(as required). Demonstrated ability to work collaboratively, identifying and reporting operational issues and process improvement opportunities. Identify ... completing operational activities associated with Dispensing, Distribution, and Inventory Management . Supports and develops Continuous Improvement initiatives, programs, and… more
- Lundbeck (Nashville, TN)
- …based on customer needs and organizational goals, incorporating "total office" account management . Local Market & Therapeutic Area Expertise - Gather and validate ... on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical… more
