- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) ... needs to CRA-Manager and/or functional vendor and internal management as needed.o Performs Quality control visits as required.Leads local study teams to high… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating ... resolution, risk mitigation and continuous improvement through strategic partnerships with Clinical Research Organizations (CROs) and vendors across all phases… more
- Merck & Co. (Rahway, NJ)
- …department, within function and cross-functionally.Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial ... Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management… more
- Catalent (St. Petersburg, FL)
- …maintains communication and collaboration with various departments such as product development, quality control , safety, metrology, quality assurance and ... approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies.The Analytical Laboratory Clerk, Research and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... Scientist position available at its Kenilworth, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with… more
- Insmed Incorporated (San Diego, CA)
- …CMC team.Perform quality management activities such as deviation, CAPA, change control , investigation of OOS, OOT and anomalous results within the company QMS ... our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1… more
- Merck & Co. (North Wales, PA)
- …experience in clinical research (eg, monitoring, data management, clinical quality assurance, study management)Experience with risk management tools and ... (eg Global Data Management & Standards (GDMS), Biostatistics & Research Decision Sciences (BARDS), Medical Monitoring, Site Monitoring), our...programs, clinical trial processes as well as quality management systems and quality control… more
- Merck & Co. (Rahway, NJ)
- …experience in clinical data management.Knowledge and Skills:-Understanding of the clinical research process with in-depth knowledge of the Clinical ... computer science, or related discipline, with at least 3 years' experience in Clinical Data Management, medical research , or database design and development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality… more
- Merck & Co. (Rahway, NJ)
- …seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... and solutions that help everyone to be more productive and enable innovation.The Research and Development Sciences (RaDS) value team in Our Company's R&D IT brings… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence ... projects across the company's Biostatistics and Research Decision Sciences (BARDS) group.- The principal statistical programmer utilizes strong expertise in multiple… more
- Merck & Co. (Ames, IA)
- …needed, to aid in delivery of product to customers, ie International Registration, Quality Control , Quality Assurance, Production, etc.Provide Sales force ... The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to Ruminant animal health.- Position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The GTL… 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 ... 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)
- Job DescriptionDescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated ... Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to studies based on indication specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, ... orMD preferred Experience Qualifications10 or More Years At least 15 years in Clinical Research in combined pharmaceutical company and Contracted Research … more
- Merck & Co. (Rahway, NJ)
- …development for large-scale recombinant protein expression in mammalian systemsKnowledge of Quality by Design, Process Characterization and Control Strategy ... Job DescriptionOur Research Scientists are our Inventors.- Using innovative thinking,...achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research , Research , ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Deliver the… more