- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... and identifying areas of potential non-compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line with company-wide policy… 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
- 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
- Genmab (NJ)
- …Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve… more
- Genmab (NJ)
- … submission (NDA, BLA, MAA) highly preferred.Solid understanding of clinical development and regulatory frameworks, including GCP and ICH guidelines.Proficiency ... ready to make a meaningful impact in oncology drug development and be part of a dynamic, collaborative team...are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy , Regulatory , Legal, IT, Trade, Patient Safety and Compliance. ... affordability program vendors. Essential Functions Partners with vendors and oversees development of program business rules and operations Collaborates with cross… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and benefit from a range of possibilities for professional and personal development . Are you ready? The Position Responsible for leading process, reporting and ... US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent...also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development , Biologics Process Research and Development , CMC and Regulatory in aspects of control strategy and filings, ... development plans of personnel under their direction within the framework of Company policy . The Executive Director will be a manager of managers, with keen… more
- Genmab (NJ)
- …preferredExperience working with FDA, EMA, and ICH guidance for drug development pertaining to statisticsExperience with the relevant regulatory requirements ... us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development , and ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers… more
- AITHERAS, LLC (Ashburn, VA)
- …required) Preferred Qualifications: + Certified Records Manager (CRM) + Federal regulatory compliance experience + Policy development and training ... Senior Archivist / Records Manager Department: CBP Contract Location: Ashburn, VA Job...specialize in Data Analytics, Cloud Computing, IT Engineering, Application Development , and Cyber Security. Based in Rockville, MD, we're… more
- AITHERAS, LLC (Ashburn, VA)
- …required) Preferred Qualifications: + Certified Records Manager (CRM) + Federal regulatory compliance experience + Policy development and training ... Mid-Level Archivist / Records Manager Department: CBP Contract Location: Ashburn, VA Job...specialize in Data Analytics, Cloud Computing, IT Engineering, Application Development , and Cyber Security. Based in Rockville, MD, we're… more
- Novant Health (Wilmington, NC)
- …of education and training processes across the organization for NH Document Manager system processes and the development of policies and procedures ... the basic standards for document formatting and routing management including policy /procedure development , design, and storage standards. + Performs various… more
- Saratoga Hospital (Saratoga Springs, NY)
- …hospital regulatory experience or specifically related to clinical regulatory , policy familiarity, MCN Policy Manager experience preferred. Pay Range ... and DOH. In addition, this position will support the development of a standardized organizational dyad structure with the... of a standardized organizational dyad structure with the Policy and Regulatory Readiness Manager … more
- RWJBarnabas Health (Somerset, NJ)
- …administration, regulatory compliance, accreditation or licensure associate, business development or operations manager . + Minimum three years' experience ... Regulatory Planning Manager (Hybrid) - Somerset,... standards and interpretations to assist in program design, development and compliance. Manager prepares, as necessary,… more
- TD Bank (Mount Laurel, NJ)
- …in the general description below. **Job Summary:** The Compliance Governance & Operations Manager leads the development and implementation (or lead support) of ... regulatory bodies and TD internal groups + Leads development of team procedures and governance processes and advises...want to help you succeed. You'll have regular career, development , and performance conversations with your manager ,… more
- Liberty Utilities (Rio Rico, AZ)
- Manager , Rates and Regulatory Affairs Litchfield Park, AZ, US, 85340Sierra Vista, AZ, US, 85635Gold Canyon, AZ, US, 85118Surprise, AZ, US, 85387Goodyear, AZ, US, ... outcome and how we achieve it. **Purpose** As the Manager of Rates & Regulatory Affairs, you'll...+ Provide coaching and leadership to the team, identifying development opportunities and building a high-performing regulatory … more
