- 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
- 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)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end ... procedures, quality standards and adverse event reporting-requirements internally and externally.The Clinical Research Manager (CRM) could be responsible for a… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sources, both internally (eg, Global R&D, US Competitive Intelligence, Managed Markets, Clinical Insights, Medical Affairs , Scientific Center of Excellence) and ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on ... or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol… 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
- Novo Nordisk Inc. (Minneapolis, MN)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Merck & Co. (North Wales, PA)
- …Translational Medicine, Global Medical and Scientific Affairs , and Global Regulatory Affairs and Clinical Safety to identify key issues for publications, ... and posters/oral presentations that report results from our company oncology clinical trial program, as well as select early-stage development projects and… more
- Aequor (Thousand Oaks, CA)
- …and timing are understood. ? Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs , Corporate Planning, and ... Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit...Details: Under minimal supervision, manage demand and supply of Pre- Clinical and Phase I Clinical Programs. The… 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
- 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
- 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
- Teleflex (Morrisville, NC)
- Clinical Affairs Manager **Date:** May 23, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 50% **Requisition ID** ... solutions that make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides clinical expertise, insight and support… more
