- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Eisai, Inc (Exton, PA)
- …to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take… more
- Eisai, Inc (NJ)
- …contract research organization or other relevant providers. Knowledge of clinical research process and regulatory environment Demonstrates ... Suite#LI-TS1Eisai Salary Transparency Language:The base salary range for the Manager , Clinical Outsourcing is from :102,100-134,000Under current guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-interventional, Managed Access Programs, Investigator initiated studies and Collaborative Research .Support adherence to regulatory safety requirements for ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummarySupport the PVQA… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary The ... Biosample Operations Manager , Biosample Management is responsible for supporting the oversight...lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Manager , ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and develops ... HEOR, Future Business Strategy, Commercial, Account Management, Analytics, Legal, Regulatory , Investor Relations, Value Communication and Contracting Strategy colleagues,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary: This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term ... market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs… 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 ... (MD, DO, PhD, or PharmD required A minimum of 5 years of combined clinical , research or Pharma experience required Experience in relevant therapeutic area… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... Description: Senior Specialist, Project Management- Drug Development The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late… 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 ... their rotations. Additional key internal relationships may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... Job DescriptionThe drug development Project Manager is part of Global Project and Alliance...Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company.- Position Description/Summary:… 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 ... MA project management, Medical Communications, Clinical Trial Management, Clinical Development and Outcomes Research Marketing and Market development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files… more
