- 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 ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Insmed Incorporated (Bridgewater, NJ)
- …the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and documentation (lab manual, protocol, report, ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… 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 ... External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects ... review and final approval for all submissions and associated documentation . Provides expertise as worldwide regulatory representative to Product Development… 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 ... issues. Serves as an expert regarding case processing issues and required documentation and investigation of product complaints. Serves as the key contact person… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior ... and assumption documents to support accurate filings and internal documentation Responsible for supporting government attestations and the transactional and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to internal and external manufacturing sites. Review technical documentation (protocols, reports) associated with manufacturing, technology transfer, site-to-site ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director of Oncology Imaging Science and Oversight will be a member of the ... strategy for early and late phase study protocols with imaging-based endpoints. The Director will be a main point of contact for the processes associated with… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… 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 ... Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... Joint-GPT as applicable.Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.Keeps current with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …prioritize, mitigate and monitor risks and supportEnsure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and ... functions, geographies and levels of the organizationEnsure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... and proactively represented at program level and along the clinical trial process in support of a proactive quality...KQIs at the respective GPTs and prepare respective management documentation for the QA Head for review at the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Kolmac (Columbia, MD)
- …hours of supervision and submit it to the Regional Director of Clinical OperationsEnsures completion of clinical documentation including Treatment plans, ... Kolmac Integrated Behavioral Health is seeking a Clinical Director (w/ Substance Use Disorder...IOP appointments, quality of care including timely discharges and documentation are being met. Will provide daily/weekly updates to… 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 ... The Position Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance with… more
- Merck & Co. (Rahway, NJ)
- …play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report ... to the Director , Engineering, Automation Lead position and will be a...non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities.- In this role, you will be… more
- Aequor (West Chester, PA)
- …plans across products or indications. The S/MMC reports to the Director of Medical Communications. Travel Requirements: Regional and/or international travel travel ... S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates… more
