- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various department projects to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Liaison team and other NNI units / personnel. Organized Provider Accounts, project and team leading responsibilities for FMA; contributes to the representation of ... time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory responsibility… more
- Merck & Co. (South San Francisco, CA)
- …Scanning, Healthcare Account Management, Healthcare Technology, Innovation, Internal Project Management, Management Process, Promotional Review , Risk ... Job DescriptionGlobal Project and Alliance Management (GPAM) resides within the...R&D partners.Position Description/Summary:Under the broad direction of the Senior Director or Director , Strategic Alliances, the Associate… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director Pulmonary Hypertension, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) (referred to as EDMA) is ... with V&I Outcomes ResearchSupports the Investigator-Initiated Study programLeads talent review process and demonstrates follow-through on Development Plans for Key… more
- Merck & Co. (North Wales, PA)
- …Skills:Hematology, Medical Affairs, Medical Communications, Medical Knowledge, Medical Review , Medical Writing, Pharmaceutical Medical Affairs, Project ... Job DescriptionRole SummaryThe Associate Director , Global Scientific & Value Content-Healthcare Professional (AD,...GSVC Annual Product Plans. This includes leading the development, review and communication of GSVC individual content within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This level handles escalated global CSPV case processing issue and handles project . This position prepares trainings, supports CAPA investigations, case review , ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Formation Bio (New York, NY)
- …patients faster and more efficiently.About the PositionWe are seeking an Associate Director , Program Management to drive the execution of critical drug development ... Implement program management best practices, including standardized reporting and review processes. Develop scalable solutions for common program challenges, such… more
- BioAgilytix (San Diego, CA)
- …with Project Managers to discuss new projects, prepare and review study exhibits, and maintain pricing consistency.Maintain client communication through weekly ... regulatory compliance across both functions, supervising up to 40 employees.The Director will focus approximately 95% of their oversight on regulated bioanalytical… more
- Eisai, Inc (Nutley, NJ)
- …user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical Programming will ... profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical...and SAS program development for clinical data processing, data review reports and listings. This includes but is not… more
- Merck & Co. (Rahway, NJ)
- …contractors including Good Manufacturing Practice (GMP) qualification as well as site/ project selection.Additionally, the incumbent would serve as the bridge between ... the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel to discuss projects,… more
- Eisai, Inc (Exton, PA)
- …supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible...R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe purpose of the Senior Director , Forecasting & Business Analytics is to lead the forecasting and financial ... and due diligence efforts and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively inform them of the timelines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... planned, communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within… more
- Merck & Co. (Rahway, NJ)
- …work of Engineering Firms and supplier/vendors (no direct reports) to progress project related deliverables. Participate in development and review of engineering ... Job DescriptionDUTIES:Responsible for complex workstreams and implement capital project scope and technical studies that support business objectives, with focus on… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities ... timelines, and support decision-making in biologics development and manufacturing. Project Management Own CMC timelines, budgets, and resources across biologics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position has advanced skills in continuous improvement, project management, change management, and risk managementResponsibilities: Leadership, Direction, ... department level.Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership teams). Functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates ... Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners… more
