- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... hybrid position. Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory, quality assurance and other requirements when ... this leader enables all activities related to the successful acquisition of high- quality goods/services at the best possible prices and business terms for NNI.… 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...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory ... research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Business Systems and Process Improvement leads procurement efficiency and continuous improvement initiatives within Animal Health ... like RPA, Celonis, and AERA. Reporting to the Vice President of AH-GSM, the Director is a key member of the leadership team driving digital transformation withing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for developing and continually growing strong relationships with DS internal senior stakeholders to assess, develop, implement and drive execution of Strategic ... responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Merck & Co. (Rahway, NJ)
- … mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Merck & Co. (Rahway, NJ)
- …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial data… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …groups and cross functional partners.Key Responsibilities Represent MSAT at joint quality and CMC committeesPartner closely with senior Janssen leadership ... templatesServe as an SME for global initiatives related to quality / compliance /validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and compliance . Relationships This role reports to the Associate Director -Patient CRM Product Owner. Collaborates cross-functionally with internal teams, such as ... Solutions across multiple therapeutic areas at Novo Nordisk Inc., (NNI). The Senior Manager Patient Solutions will be responsible for delivering the vision spread… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Merck & Co. (Rahway, NJ)
- …company's strategy; this includes a deeper knowledge of internal controls, business compliance , and risk management. Individuals will be based in the global ... in Rahway, NJ.ResponsibilitiesUnder the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the FLDP participant will:Participate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …2 days remote. Approximately 20-30% overnight travel. Global Job level: Director Development of People Ensure that reporting personnel have individual development ... strategies to guide customer experiences Strong understanding of regulatory, compliance , and ethical considerations in engaging with healthcare providers Proven… more
- Credit Acceptance Corporation (Atlanta, GA)
- …Python, SAS, MATLAB, etc.Expert knowledge of SQL and relational databases ( Senior Manager/ Director )Expert knowledge of Microsoft Excel and PowerPointStrong ... bureaus with the ability to oversee and solve complicated technical problems ( Director )Ability to confidently interact with senior business leaders ( Director… more
- Lennar Homes (Brea, CA)
- …and exceptional services. Join a Company that Empowers you to Build your FutureThe Director of Compliance and Risk Management reports directly to the General ... Counsel. The Director of Compliance and Risk Management will...needed. Providing ongoing supervision, training and evaluation of the Quality Assurance and Compliance (QAC) staff in… more
