- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience as a Clinical Trial/Project Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are...difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and develops ... and consultants. Essential Functions Support key cell therapy market and pricing research strategy initiatives in the US and in collaboration with Global Market… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …direct implications for account team planning and implementation. Entails coordinating market research and development of access and ARP scenarios to ensure launch ... scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making Assesses investments in payer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …patient services operations, pharmaceutical sales, marketing, market insights, market research , contracting, managed markets strategy, or value communication within ... of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans, forecasting, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and other strategic initiatives. This includes, but is not limited to: Research , Product Development, Clinical Development, Regulatory Affairs, CMC, New ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory, and commercial scenarios Prepare clear and concise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Provide support ... for all aspects of Global Clinical Operations with a high degree of quality in...and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food… 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 This position ... supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This...and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… 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 purpose ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummarySupport the PVQA ... interventional, non-interventional, investigator-initiated trials, Managed Access programs and Collaborative Research to the highest quality standards globally end-to-end end… 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. SummaryAs a ... Manager , Generative AI, you will be responsible for conceptualizing,...AI solutions that align with their needs. Drive the research , development, and implementation of generative AI models and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position is ... the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and… 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 Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...§ 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting… 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: Manager , ... coaching for progressive skills development; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care overview, as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary:Accountable to ... commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary: This position ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position is ... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical Sub-team and… 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 Reviews and ... career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol Development, Statistical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality support in clinical manufacture or NPI is preferred.Experience in clinical quality, method development, cell banking, or Research & Development is ... of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment. Reviews,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files… more
