- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide...optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be a key ... to understand training needs and translate into actionable and enriching associate learning curricula and fostering connections among commercial associates. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR ... processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. Collaborates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements and seeks agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement ... About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director ... digital forensics investigations.Key Responsibilities:Laboratory Supervision and Management:-Oversee the day-to-day operations of the digital forensics lab, ensuring all activities… more
- Merck & Co. (Rahway, NJ)
- …that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor… more
- Merck & Co. (Rahway, NJ)
- …technical, and operational experience to lead and support facility operations , process development activities, compliance investigations/change management, ... pilot plant. The Facility Lead position reports to the Director of Operations /Head of SSO Pilot Plant...as appropriate. Collaborate closely with development engineers & chemists, compliance representatives, and other team members to ensure the… more
- Merck & Co. (Rahway, NJ)
- …Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, PIE, ... prioritization, new asset, portfolio considerations to support the PPS director /PRT LT partnership &-prioritization-- Support PPS team on facilitation of… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... to onboard new technologies, facilitate tech transfer, and ensure efficient operations . Communication, organization, and solid controls experience will be critical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the… more
- Merck & Co. (Rahway, NJ)
- …action plan (incl. sharing of results and training of local country operations , if required). -Quality / Compliance / Privacy IssueEscalation: ... compliance issues (incl. any potential trends) to local country operations management and RCQM.Escalates significant quality/ compliance issues and supports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with… more
