- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Director , Clinical Development Join a Legacy...Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … data between partners in relation to marketed and clinical products.Strategic Partner Management :Oversees Local/Global PV service providers responsible ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a ... of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, ... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Certification - Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in a medical ... coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- Genmab (Plainsboro, NJ)
- …management , process and continuous improvement management , digital or data technology, operations, supply chain, manufacturing, ERP, clinical supply ... authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global … more
- Genmab (Plainsboro, NJ)
- …is assigned to a trial the GCTM takes on the CTM role too.ResponsibilitiesLead the Clinical Trial Team (CTT) and Trial Management (TM) teamDefine and align CTT ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Director , Clinical Informatics in the Clinical Data Science & Evidence (CDSE) department ... of "best practices" in informatics and associated contingencies to include healthcare and clinical data analytics, real-world data sources, data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Senior, Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE) department of NNI focused on ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… 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...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
