- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leadership team and oversees NNI due diligence and other senior level oversight associated with the role Internal/external relationships:… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...strategy they will provide valuable support and consultation to Senior Leaders in the Line of Business. In this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization. Relationships The Director -Patient Centered Outcomes Research reports directly to a Senior Director within the CDSE RWE team. This is a US ... experience data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early...can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... 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
- 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position The Senior Manager, Site Engagement is responsible for the management… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that ... ability to travel over 50 %.Head, Medical Science Liaisons (MSLs) / Director , Medical Training, Pain therapeutic space is responsible for field leadership of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leading and executing economic modeling projects. Relationships This position reports to the Senior Director , HEOR Modeling. The role works alongside with other ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research vendors, & budget management. RelationshipsThe fellow will report to the Senior Director RWE during the program and will work closely ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …awareness across the customer 's organizational structure. Relationships This position reports into a Director or Senior Director within the Area or National ... as well as the full range of treatment options available and associated clinical outcomes Leverages detailed knowledge of both Novo Nordisk and competitor products… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is responsible ... of critical quality risks and issues that may affect BMS. The Senior Director , Clinical Quality Audit strategy is also responsible for effectively… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development... results and provide a guidance to prepare high quality reports working with Medical Writing + Working with ... within the respiratory clinical development program at Teva! The Senior Director , Clinical Development is responsible for the development, execution and… more
- Novo Nordisk (Plainsboro, NJ)
- …from either academia or industry. In this role, the Senior International Medical Director will be the medical lead for clinical development of projects in ... within the therapeutic area, including PRO and biomarker strategies. Relationships Reports to: Senior Director of the Liver Disease department. Work with the … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and assuring effectiveness in delivery on quality objectives and a strong quality voice. Additionally, the Senior Director will collaborate closely with ... by advancing the care of patients with life-threatening diseases. ** Senior Director , GVP** **Audits** The Senior...for driving the integration and peak performance of R&D's Quality Management System, across Clinical Development and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical ... The Director Clinical Sciences, Hematology, leads in...and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional… more
- Genesis Healthcare (Easton, PA)
- …expertise with our Clinicians in Action professional development program. Responsibilities The Clinical Operations Area Director PTA is responsible for efficient ... responsible for marketing rehabilitation services in the region. The Clinical Operations Area Director PTA monitors the...clinical orientation and ensures that there is a quality orientation process for new rehab staff. 18. Oversight… more
