- Organon & Co. (Jersey City, NJ)
- …also be responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, ... INDs, briefing books and other regulatory documents, as applicable. The Associate Director, Biopharmaceutics will...for primary and global markets. Interpret study results and review study protocol and study report as the biopharmaceutics… more
- Insmed Incorporated (NJ)
- …throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements. This role will support implementation and ongoing management of ... maintenance, and retirement) to ensure compliance with FDA, ICH, and EU regulations. Review and approve computer system validation (CSV) deliverables (eg, URS, FS,… more
- Cipla (Reid, WI)
- …to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of master batch records. Develops ... Creates training materials for subject matter input. Track and manage periodic review of approved procedures. Develop strategies and documents for cleaning and… more
- Houston Methodist Clear Lake Hospital (Nassau Bay, TX)
- …compliance with ethical and legal business practices and accreditation/ regulatory /government regulations. PEOPLE ESSENTIAL FUNCTIONS Directs, develops and implements ... competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees,… more
- Houston Methodist Baytown Hospital (Baytown, TX)
- …evidence-based practice using data and performance improvement methodologies and oversees the review , analysis, and integration of data in workflow design to support ... assure compliance with ethical and legal business practices and accreditation/ regulatory / government regulations. PEOPLE ESSENTIAL FUNCTIONS Performs management responsibilities… more
- Middlesex Health (Middletown, CT)
- …Essential Duties & Responsibilities Under general supervision the Tumor Registrar will; Review medical records to identify and abstract cancer cases and related ... guidelines Prepare and submit cancer registry reports to state, national, and regulatory agencies as required (eg, SEER, National Cancer Database). Ensure compliance… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data ... data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working… more
