- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preparation, set-up, and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to… 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 ... in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director....including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and… more
- BioAgilytix (Durham, NC)
- …life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities ... product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agenciesCoordinates… more
- Aequor (Newbury Park, CA)
- …- both oral and written. Ability to understand and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory ... for inclusion in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under under the direction of a… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall ... assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a regulated GCP environment or equivalent experience preferred- Experience in Clinical Safety and Pharmacovigilance preferred- Medical Affairs experience ... the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of financial budgets and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...and resource strategies within a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Compliance organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs , and Regulatory Affairs ) and support ... functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining CommunicationsPlan, create, develop/build, draft and deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and… more
- Tris Pharma (Monmouth Junction, NJ)
- …initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, ... portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs .Responsibilities- Lead the ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Merck & Co. (North Wales, PA)
- …supervision:Attend publication team meetings for planning knowledge and assist Publication Manager with note taking and meeting summary.Assist the Publication ... Manager in development and maintenance of publication plan slide...or BA plus experience in a scientific discipline or clinical research and 2 years medical communications agency, scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Consumer Strategist Manager will be a critical driver in shaping an insights-driven Consumer marketing ... Strategy Lead. Collaborates with cross-functional teams, including sales, marketing, medical affairs , Centers of Excellence (COEs), regulatory affairs , and other… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop consistent ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- Axelon Services Corporation (Atlanta, GA)
- …This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development ... studies during phases 1-4. The individual must partner closely with clinical , regulatory, quality and production associates to ensure timely delivery of supplies to… more
- Sunrise System Inc (Atlanta, GA)
- …ask for help. Working within the Global Environment / Global Teams Regulatory Affairs experience MAIN ASPECT OF ROLE: Support Aggregate Tracking process Must be able ... Description: Sr. Associate, Aggregate Report Compliance In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate,… more
- Teleflex (Hartford, CT)
- Sr. Clinical Affairs Manager , Interventional Urology **Date:** May 23, 2024 **Location:** Hartford, CT, US **Company:** Teleflex **Expected Travel** : More ... completeness. 1. Roehrborn, Can J Urol 2017 **Position Summary** TheSr. Clinical Affairs Manager , Interventional Urology delivers professional education to… more
- Danaher Corporation (Dallas, TX)
- …lives with diagnostic tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible ... the CCIA Clinical Affairs team and report to the Senior Manager Clinical Affairs who is responsible for managing the CCIA Cardiac-Reagent clinical… more
