- Genmab (Plainsboro, NJ)
- …to regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, ... and/or participate in meetings with FDA and other health authorities as appropriate Monitor and assess global and US regulatory guidelines and regulations and… more
- Genmab (Plainsboro, NJ)
- …to ensure optimal regulatory success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other ... Data Sheep and US Prescribing Information. Responsible for maintenance of the IND. Monitor and assess global and US regulatory guidelines and regulations and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Experience in managing/monitoring clinical research sites (in-house or on-site) prior onsite ... About the Department The Clinical , Medical and Regulatory (CMR) department...Nordisk (eg Investigators and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and… 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 ... least 10 of those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) A minimum… more
- Genmab (Plainsboro, NJ)
- …candidates through IND enabling studies in close collaboration with Translational Research , Toxicology, DMPK, and other functionsManage clinical pharmacology, ... purpose.Genmab is looking for a dynamic, science-driven people leader to head our Clinical Pharmacology & Quantitative Sciences team. Do you get excited by our well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO ... with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Genmab (Plainsboro, NJ)
- …market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.This ... regional strategies and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to… more
- Genmab (Plainsboro, NJ)
- …Lead creation and review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, ... protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] supporting registration, market… more
- Genmab (Plainsboro, NJ)
- …healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We ... regional strategies and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand performance and patient outcomes Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. ... areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, Development, innovation hubs across NN, other affiliates, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive market share and revenue growth Market Research : Support market research efforts and monitor competitive landscape to identify trends, competitive ... industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , and clinical processes In depth understanding of disease… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …crisis management Understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes preferred Ensures timely execution ... Market Access & Public Affairs, Trade, Legal, Compliance, Finance, HEOR, and Market Research . The position has high exposure to senior management and requires a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Ensures timely execution and follow-up. ... Market Access & Public Affairs, Trade, Legal, Compliance, Finance, HEOR, and Market Research . The position has high exposure to senior management and requires a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term ... Market Access & Public Affairs, Trade, Legal, Compliance, Finance, HEOR, and Market Research . The position has high exposure to senior management and requires a… more
- Genmab (Plainsboro, NJ)
- …functions responsible for value proposition enablement with a focus on clinical , commercial, regulatory , medical affairs, and HEOR stakeholders,Proactively ... the value of assigned asset(s),Provide strategic market access input to inform global clinical development program of assigned asset(s) and ensure it is optimized to… 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 ... Customer Experience and Marketing Enablement, Employee Experience, Public Affairs, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch Office,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …providing regular updates to leadership Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, and other relevant NNI departments to ensure alignment of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a Manager,… more
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