- 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
- Merck & Co. (Rahway, NJ)
- …therapeutic areaProven ability to effectively influence company life cycle management and data generationUnderstanding of resourcing and budgetingCurrent ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I… more
- Merck & Co. (Rahway, NJ)
- … Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:01/31/2025 *A job ... Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he...modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to… 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
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …(BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP ... managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well as release and… 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
- Merck & Co. (Rahway, NJ)
- … Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:01/18/2025 *A job ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… 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
- Merck & Co. (Rahway, NJ)
- …the role of Director . QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical ... Job Description Director -QP2-IO We are seeking an experienced talented...Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:01/31/2025 *A job… 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
- Merck & Co. (Rahway, NJ)
- …processes communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a...the portfolio overall and each product has robust lifecycle management plans, appropriate and rigorous technical support processes to… 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
- Insmed Incorporated (New York, NY)
- …strong related experience.Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management /trial experience and 2 years clinical ... and/or product support of appropriate prescribing, improved patient outcomes.Present data on Insmed products to HCPs including physicians, academic institutions,… 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
