- 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 ... you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include delivering high-performing teams across designated therapeutic areas that lead to best-in-class field teams and defining capabilities and frameworks ... for patient support field teams. This role will oversee program operations , compliance, vendor contracts and relationship management. AD will drive collaboration and… 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 ... difference? The Position This position is responsible for managing the day-to-day operations of Patient Safey & Technical Complaints Contact Center. This role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company initiatives and functions such as Marketing, IT, Clinical , Research, Operations , Patient Support Programs, and Digital Health Lead cross functional ... Share specialized knowledge and insights to enhance the team's overall capabilities Lead by example in demonstrating best practices and ethical standards in legal… 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 ... Director is a key Leadership Team member and advisor on Patient Safety Operations including handling of all safety case processing activities for adverse events… 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 ... responsible for overseeing the initial evaluation of technical complaints for US Operations (USO) post-marketed products from all the sources. This role is crucial… 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 ... oversight of Vendors and management of ICSR Verification teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …entire Market Access & Public Affairs Team, PCOR (Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal ... of the activities described below Drive Formulary Placement For NNI Products Independent lead within NNI to develop RFP response for the targeted customers, manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), including USO President/Executive Office, Commercial, Market Access and Public ... Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams...response strategy and public responses Serves as Media Relations lead for USO Crisis Response Teams (CRTs), as required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will ... and risk management. Responsibilities Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of 7 years relevant experience required- Experience Qualifications- Experience in global clinical operations methods and processes in industry setting is ... detail are required. The SDL is an experience matrix leader and serves as a mentor to more junior...complete study team list is maintained.-In partnership with the lead physician, Clinical Scientist and all study… more
- Parexel (Trenton, NJ)
- **PXL is seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the ... - Advanced excel knowledge required - 7+ years of experience in clinical operations preferred. **Education:** - Bachelor's or master's degree. **Experience:**… more
- Terumo Medical Corporation (Somerset, NJ)
- …and minimum 5 years of experience in clinical quality assurance or clinical quality operations or a combination of relevant experience, training, and ... Sr. Clinical Quality Specialist Date: Oct 21, 2025 Req...with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell ... Leads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …up, model the way and enable the team to act.Provides medical leadership to:- GMA clinical operations teams as part of evidence generation forums and study teams ... research areas centered around rare diseases and immune disorders. SummaryMedical Affairs leader for the portfolio of early asset compounds under the supervision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. We are currently seeking a Biosample Management Operations Intern from June 2026 - May 2027. This position will be full-time ... for biorepository vendors responsible for long-term storage.Assist the Biorepository Lead and Head of BSM as needed to manage...to manage the communication with Precision Medicine and the clinical study teams to address informed consent and IRB/EC… more
- Parexel (Trenton, NJ)
- Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical ... Operations Management** Study Team Support + Supports individual clinical study teams as required for all technical and...Acquisition and Management + Works closely with data management lead to determine how sample and testing data will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and ... Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with… more
