- Novo Nordisk Inc. (Plainsboro, NJ)
- …functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned ... stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East Coast Development Hub. Key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, ... Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, ... strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For Phase 2… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting...both classroom setting and individual interactions Support the creation, assessment and closure as needed of corrective actions, change… more
- Eisai, Inc (Nutley, NJ)
- …data privacy standards. Your responsibilities span security operations, risk assessment , investigations, and compliance issue resolution for the Americas business. ... Security and Data Privacy standards through continual risk and security assessment .Collaborates with global stakeholders from EIT and leaders across regions in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will ... Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset Leads who… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in ... safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Insmed Incorporated (Bridgewater, NJ)
- …Scientific Communications. The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums. Position may be located in the ... Model, Medical Expert Engagement Planning, Coaching Framework, Field Impact Assessment , MSL functional onboarding, Clinical Trial Support Framework, etcOperational… more
- Insmed Incorporated (Bridgewater, NJ)
- …communications deliverables across the Insmed respiratory franchise. This role will lead the development and maintenance of scientific platforms and the strategic ... about Insmed disease areas of interest and Insmed generated data. As the lead for global congress strategy in their assigned therapeutic area, the Director will… more
- Merck & Co. (Rahway, NJ)
- …Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to lead projects and progress deliverables. - The Director would be responsible ... understand lean design and delivery, implement standard work and be able to lead technical areas and large capital projects from an end to end perspective.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders such as GMP QA, specifically for GDP requirements, risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance ... targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within CSPV function.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration to meet the ever-changing global needs for Daiichi Sankyo. Will lead project and change management for complex, cross-functional initiatives for global ... process improvement, change management and analytics. In addition, this position will lead and support divisional and departmental level objectives for Asset &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategic imperatives, training and onboarding, metrics activities, participate in GCO vendor assessment , and tracking od vendors and assessment status. In ... addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and...IO tools.-Assist with the tracking of vendors - vendor assessment status and final choices, in collaboration with RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access strategy development and partner with ... Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the development of innovative / impactful pricing, reimbursement,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ... data review per Integrated Data Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety… more
- Merck & Co. (Rahway, NJ)
- …Division. The primary role of the successful candidate will be to lead the design, method development, optimization and transfer of immune- and cell-based ... sections of regulatory submissions and associated source technical reports and risk assessment documents. The ideal candidate should bring expertise in a wide… more
- Merck & Co. (Rahway, NJ)
- …oriented and strong project/time management skillsAbility to identify and lead process improvementsStrong problem solving and ability to develop corrective ... business negotiation skills conducted in a professional mannerAbility to lead , coach and mentorProficiency in data management and analysisCapability to… more
- Merck & Co. (Rahway, NJ)
- …business, understand lean design and delivery, implement standard work and be able to lead technical areas and small capital projects from an end to end perspective. ... Language This position will function as the technical/engineering process lead engineer/project design manager with prior experience supporting Biologics, Vaccine… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to enhance investigation quality, timeliness, and productivity.Key Responsibilities Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate ... Director to co- lead the deviation investigations management system. Ensure alignment with GMP regulations and organizational objectives in all investigation… more
- Insmed Incorporated (Bridgewater, NJ)
- …high visibility within the medical organization and requires the ability to lead cross-functional teams in a matrixed organization. The Director will work closely ... publication strategy budget overseeing vendor selectionPartner with the Scientific Communications lead to support the incorporation of published data into medical… more
