- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Merck & Co. (Rahway, NJ)
- …and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager , CRM (Clinical Research Manager , TA Head and CRD (Clinical ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts...of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations,… more
- Merck & Co. (Rahway, NJ)
- … problems and-escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA- Manager , CRM (Clinical Research Manager ), TA Head and CRD ... Job DescriptionWith support of Sr CRA (Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager -throughout all phases… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position will ... be part of the Compliance organization and will report...business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and… more
- Lundbeck (Bronx, NY)
- …and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... contracts and compliance of the Office of Research Contracts (ORC).The Contracts Manager - Federal...DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Lundbeck (Chicago, IL)
- …of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing the ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customer service. Essential Functions Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific ... Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate… more
- Lundbeck (Rockford, IL)
- …neurology and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our ... addition to other payer channels including Medicaid and Commercial. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Lundbeck (Queens, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, Development, innovation hubs across NN, other affiliates, and ... collaborators, as we embark on shaping our future. The Position The Senior Manager - New Product Commercialization (NPC) and 5D will lead and execute strategic… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of ... ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Assist in ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Merck & Co. (Durham, NC)
- …Controllers (PLC), robotics)Maintenance Equipment (eg tools and calibration equipment) Compliance : Ensure that maintenance activities are executed in compliance ... determine root cause, and implement robust CAPAs for any team related compliance discrepancies noted during day-to-day activities and/or audits. -Escalate as per IPT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon ... and IRB/REB/ regulatory approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP… more
