- Careerbuilder-US (Suwanee, GA)
- …the daily objectives are met on each project to complete it all with quality workmanship, on-time completion, and to be under budget. Salary is commensurate with ... experience. This is in-office position. For immediate consideration please forward your resume to darrel@jrp-atlanta.com . Confidentiality assured! THIS IS A PERMANENT DIRECT HIRE ROLE AND OUR FEES ARE ALWAYS ASSUMED BY THE HIRING COMPANY. more
- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety is responsible ... cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate and communicate safety … more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… 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 ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
- Merck & Co. (Rahway, NJ)
- …are available in some 150 markets.Accountable for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal ... success.Primary Responsibilities: Demonstrate accountability and responsibility for Environment, Health, Safety and Sustainability (EHS&S) performance and compliance through active… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Insmed Incorporated (Bridgewater, NJ)
- …products in development and on the market.Accountable for the delivery of high quality and timely medical safety deliverables. Provides content guidance and ... regulatory responses for other Medical Safety Leads.Maintain and evaluate Medical Safety metrics and quality plan, including execution of metric reports,… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert ... of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating closely… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... assessments to prioritize investigations based on potential impact on product quality , patient safety , and regulatory compliance. Address recurring deviations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.- Coordinate ... as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or… 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 ... and external resources as appropriate. Relationships Reports to the Executive Director of Forecasting & Strategic Finance. Internal relationships include SVPs of… more
- Merck & Co. (Rahway, NJ)
- …with a matrixed reporting relationship to functional groups in development, quality , safety , facilities management, analytical, finance and regulatory.-FLEx was ... and behavioral dimensions.Member of site and global leadership committees (eg safety , quality ).Education:BS or MS degree in Chemical Engineering, Biochemical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the...on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse… more
- Merck & Co. (Rahway, NJ)
- …support our organization's target and biomarker discovery, chemistry, Biologics, Vaccines, safety , and process and analytical R&D efforts. The ideal candidate will ... data related to target and biomarker discovery, chemistry, Biologics, Vaccines, safety , and process and analytical R&D.Collaborate with cross-functional teams to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support:… more
- Insmed Incorporated (Bridgewater, NJ)
- …modalities.Assure bioanalytical tasks are executed to high scientific standards, with quality , and within agreed timelines. This entails overseeing work by internal ... external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety , contract research organizations etc.) to build and to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for ... measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more