- Merck & Co. (Rahway, NJ)
- …to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...associated with the manufacturing of company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in ... to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Our...substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… 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 and ... centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product...(especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... accountable for the full technology stack across all aspects of Operations, Supply, Quality and Business support at the Millsboro site. The Site Digital Technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and… 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
- 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 ... date with the latest methodologies and insights. Relationships Reports to the SR Director Sales Reporting & GtN. Internal relationships include Senior HQ & local… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical ... MW for the CSR; Leads indication specific surveillance and safety summaries, such as Section 2.7.3 of eCTD.Study Strategy:...strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and… more
- Catalent (Harman, WV)
- …stakeholder satisfaction.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, ... Senior Director , Supply Chain Position Summary: The Senior ...applicable regulatory SOP and cGMP guidelines.Manages processes to optimize quality performance and on-time delivery to insure customer satisfaction.Establishes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submissionManage CRO to ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE)- Direct Project Support:… 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 ... focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include… 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)
- …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
- 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
- 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)
- …and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs ... the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document… more
