- Insmed Incorporated (Columbus, OH)
- …COLLABORATION, INTEGRITY, RESPECT and ACCOUNTABILITY to the highest standards The Therapeutic Specialist will possess a high clinical aptitude and seasoned ... of trust, respect, and commitment to winning the right way (culture of compliance ) Foster an entrepreneurial spirit with a focus on ownership and accountability to… more
- Merck & Co. (North Wales, PA)
- …in the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional ... products to produce safe, effective, innovative medicine.As a GSA Specialist you will work closely with experienced GSA team...liaison to our company's Office of General Counsel, Privacy, Compliance and Clinical Teams, as appropriate, to… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Process Engineer ... role at the Specialist level will serve as a leader in the...a leader in the FLEx Oral Solid Dosage GMP Clinical Manufacturing facility. --This role will support formulation and… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a ... to enhance standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist , Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... from the world's biomedical literature in support of regulatory, clinical research, marketing, and legal functions.- Plans, organizes, monitors, coordinates,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant Good x (eg clinical , distribution, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ensure that the QMS is aligned, maintained, and in compliance with local/global set-up and internal/external requirements Promote knowledge… more
- Merck & Co. (Rahway, NJ)
- Job Description SSO Operations Specialist Job Description The Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility ... and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities while… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, Engineering, ... utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation engineer… 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 ... and non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities.- In this role, you will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will report to the Director, ... production, utility systems and associated infrastructure.-Responsibilities of the Senior Specialist - Process/Facility Engineer include the following:The process engineer… more
- Merck & Co. (Rahway, NJ)
- …job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng position will report to the Director, ... and non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities. In this role, you will be responsible for… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities and schedule for… more
- Eisai, Inc (Nutley, NJ)
- … compliance standards. Essential Functions Develop and maintain superior clinical expertise with our brand(s) and disease state/conditions to effectively educate ... to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team...the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with… more
- Insmed Incorporated (Bridgewater, NJ)
- …mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along ... of trust, respect, and commitment to winning the right way (culture of compliance ).Foster an entrepreneurial spirit with a focus on ownership and accountability to… more
- Merck & Co. (Rahway, NJ)
- …Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory labeling point ... to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions… more
- Catalent (St. Petersburg, FL)
- QA Specialist , TrainingPosition SummarySt. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer...of every patient, consumer and Catalent employee.] The QA Specialist , Training has responsibility for all services necessary to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to...materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Systems Engineer Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. ... engineering support to implement and maintain computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Metrology Specialist as part of the Maintenance & Metrologyteam based in Raritan, NJ. ... Overview This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This ... Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Releases product based on Quality… more
