- Catalent (San Diego, CA)
- Quality Assurance Associate, Clinical SuppliesPosition Summary: Catalent Pharma in San Diego, CA is hiring a Quality Assurance (QA) Associate, Clinical Supplies ... development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... external partners relevant to the design & implementation of clinical trials improvement /innovation projects for NACD &...those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical… more
- Eisai, Inc (NJ)
- … Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...all applicable source materialCollaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin Ops. etc. to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs ... and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical ... is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... perform vendor feasibility (RFI); partner with imaging vendors to standardize documentation , processes, and software applications to ensure consistency across the DS… more
- Catalent (San Diego, CA)
- …San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with ... site culture of Safety, Quality performance, Operational Excellence, continuous improvement , error reduction, regulatory compliance, and sound fiscal responsibility.… more
- Catalent (Manassas, VA)
- …2nd Shift is responsible for creating and maintaining the Quality System documentation . Communicate any deviations to management. Assist the Quality Assurance team ... is a site based positionThe Role:Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure… more
- Catalent (Harman, WV)
- …Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group ... drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and subsequent manufacturing campaignsMaintain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure compliance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment. Reviews, ... inspection plan and record results to complete receipt process. Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …engineering support to implement and maintain computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... management, life cycle management, issues, deviations, corrections, remediation and improvement efforts of computerized systems for facility, equipment, systems and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Overview This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Aid in the development of manufacturing processes including appropriate documentation . Drive continuous improvement of manufacturing operations leveraging ... team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good...information in a clear, concise, format according to Good Documentation Practices (GDP). Perform tasks on time in a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Aid in the development of manufacturing gowning processes including appropriate documentation . Drive continuous improvement of gowning techniques and processes ... regulations. Key Responsibilities Support the Gowning Training Program responsible for clinical and commercial operation in a controlled current Good Manufacturing… more
- Froedtert South (Kenosha, WI)
- …DRG, and documents potential working DRGs up until patient discharge. Facilitates necessary clinical documentation in the medical record through verbal and ... written communication with clinicians. Evaluates clinical documentation patterns to identify areas for improvement , identifies changes which will proactively… more
- University Medical Center of El Paso (El Paso, TX)
- …Experience: A. Work Experience Three years experience in direct patient care medical / clinical environment. Eight years of experience in healthcare application ... and assists in addressing or escalating accordingly. Identifies opportunities for improvement to increase team's effectiveness and efficiency and develop action… more
