- Tris Pharma (Monmouth Junction, NJ)
- …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...related to GCP and is the primary liaison with Health Authority and Partners during internal audits and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... research organizations, and study investigatorsManage vendor budget and activitiesOversee the quality and timeline of vendor workCollaborate with study medical lead… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the Director , ... Responsibilities include the following:The process/facility lead role at the Associate Director level will serve as a technical mentor and operations team… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of ... DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… 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)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... reviewing CMC information and data, authoring CMC submissions, and interacting with Health Authorities to meet the aggressive timelines for the assigned projects.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and...lock, creating Clinical Study Report, and submission to the Health Authorities. Ensure that CS's within their group receive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions… more
- Merck & Co. (Rahway, NJ)
- …Close partnership with colleagues from Formulation Sciences, Device Development, Quality , Regulatory Affairs, Engineering, and Analytical will be required to ... skills.The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply.- Primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...new medicines for patients. We recognize that improving human health starts here and that patients rely on us.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.-… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has responsibility for the ... approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego,… 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 for ... adjudication committee setupStudy outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract ... of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also works on ... activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.Drug Development Strategy:… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... 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)
- …results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial ... inquiries related to transparency, and provide strategic leadership in health literacy and compliance with global disclosure requirements. Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
