- Tris Pharma (Monmouth Junction, NJ)
- … is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...trial databases Ensures audit and inspection readiness of Drug Safety team at all times; Ensures internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Clinical Safety , will be a product safety lead or part of a product safety team , and be responsible for overall product safety strategy ... may function as a key member of the Global Product Team in collaboration with Clinical Development,...physicians and scientists responsible for a compound/ product safety , including project-specific training and coaching of team… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team . He/She will be accountable for the day-to-day direction to ... Medical Safety Team to ensure business needs and...measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments and Risk Management Plans (RMPs) and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... includes operations that support end-to-end GMP clinical supply manufacture and product /process development, as well as oversight of the Enterprise Resource Planning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring ... the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team , and Global Product Team to inform clinical development, ... teams (eg GMAT) and representing medical on cross-functional leadership teams (eg Global Product Team , Global Brand Team , etc.) Relationships with key… more
- Merck & Co. (North Wales, PA)
- …single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory ... Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development...to the committee charters (therapeutic area Document Review Committees, Product Development Team , Early Development Team… more
- Merck & Co. (Rahway, NJ)
- …(RaDS) value team in Our Company's R&D IT brings together product management, engineering, and data science expertise to enable data and technology products ... the course of human health. In the RaDS value team , the Product organization is responsible for...our organization's target and biomarker discovery, chemistry, Biologics, Vaccines, safety , and process and analytical R&D efforts. The ideal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... your potential with us? The Position As the Senior Director Supply Chain Operations and North America Demand Planning,...execution of commercial supply chain activities to ensure seamless product flow to serve all our patients. You will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to epidemiology strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, ... peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product . Research natural history of… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group to...and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients… more
- Merck & Co. (North Wales, PA)
- …and global scientific content development, review of standard response document (SRD) on product safety and efficacy, and when required, interact with HCPs to ... approach.-Review all medical information resources and standard response documents containing product safety , tolerability and efficacy data. Interact with HCPs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative ... strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For Phase 2 and Phase 3 registrational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …entire project. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the ... and helps to maximize the success of the drug product . Serves as project statistician and ensures the study...the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and… more
- Catalent (CA)
- …As an Account Director , you will join our dynamic Business Development Team and your primary role is to evaluate and assess contract development and ... Account Executive, Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an... DeliveryCatalent Pharma Solutions is recruiting for an Account Director , Pharmaceutical Softgel and Late-Stage Oral Solids. This position… more
- Merck & Co. (Durham, NC)
- …a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while ... to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend...maintaining a high efficiency and productivity level from the team members, while maintaining a focus on Safety… more
- Dietz Property Group (Marysville, OH)
- …a company we are proud of while purposely creating value for our residents, team members and clients. Dietz Property Group is seeking a Maintenance Supervisor to ... lead the maintenance team at one of our residential communities in the...projects Performing and overseeing resident service requests Ensuring exceptional product readiness Performing and overseeing grounds maintenance Maintenance inventory… more
- OSI Group (Aurora, IL)
- …and building leadership talent and capability within R&D.Lead and oversee the product development team in a dynamic a fast-paced manufacturing ... This role is responsible for directing the activity of the corporate Product Development department in support of organization objectives. This position will work… more
- Fidelity TalentSource LLC (Westlake, TX)
- Job Description:The Role As Director , IT Product Management, you will be working in a team responsible for managing products and vendors through the entire ... in support of the Datacenter and Core Network Services Team . This includes working closely with the product...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
