- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stages of commercialization.- For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs ... Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable, ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …demographics, enrollment, retention and protocol compliance for consistency with study strategy ; reviews emerging clinical data regularly; performs quality ... Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy Strategy : Drafts development plan under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree requiredCoding Certification - Certified MedDRA Coder (CMC) or equivalent preferred Experience :4+ years of clinical data management medical coding ... preferredMust have a strong understanding and utilization of medical terminology; experience in coding medical data (adverse events and concomitant medications)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic direction to Biostats Data Mgmt ... & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan;...patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …facilitation, and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information needed to ... perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are...the delivery and execution of the Global R&D QA strategy , activities, and deliverables against the R&D Oncology and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are ... partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal Department and PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job SummaryThe position develops the global safety strategy , oversees risk management activities, and recruits and develops staffing for ... stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy : Provides input to multiple aspects of the ... May participate in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Lead Experience Data Strategy **Location:** Cambridge, MA. The location will change to Morristown, MA in March 2025. 30 % of travel ... optimize process excellence and efficiency The Lead Experience Taxonomy Governance is responsible for data ...include, but not limited to + Drive Sanofi's Global experience data strategy and operating… more
- IQVIA (Parsippany, NJ)
- As the Sr Director & Strategy Lead for IQVIA's Medical Affairs Team, you will be responsible for shaping the design, development, and continuous refinement of ... expert advisors and sales teams to ensure customers have a seamless experience . **Accountabilities:** **Business Development and People Leadership** + Manage P&L of… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Core HCM and Total Workforce Technology Strategy Lead **Location** : Cambridge, MA or Bridgewater/Morristown NJ **About the Job** Ready to push ... possible. Ready to get started? **Main Responsibilities:** + **HRIS Strategy :** Lead the strategy for...+ ** Experience :** Minimum of 10 years of experience in HCM and workforce technology strategy ,… more
- Mondelez International (East Hanover, NJ)
- …strong partnerships and coach senior function leaders + Ability to create and lead change strategy and complex transformation + Ability to engage, inspire, ... International?** **Join our mission to chain our Mission to Lead the Future of Snacking. Make It Possible.** Our...+ Pre-empt future HR concerns through the use of data and analytics, workforce planning, leveraging insights to proactively… more
- Panasonic North America (Newark, NJ)
- …leap at a time. Come join our journey! **Responsibilities** **Panasonic Tariff Strategy Lead ** Click here to learn more (https://na.panasonic.com/) about how ... Position requires high level of knowledge in trade compliance and tariff mitigation strategy as well as a highly analytical, and detail-oriented skills that can… more
- Sanofi Group (Bridgewater, NJ)
- …in our Statistical Innovation Hub, you will serve as the expert lead statistician in digital biomarkers for defining novel digital endpoints or re-engineering ... guidance to other project/study statisticians, stakeholders and junior staff. + Lead the provision of technical expertise in psychometric analysis of clinical… more
- Deloitte (Morristown, NJ)
- AI/ML Data Engineering Lead (Specialist Master) -... Strategy & Business Transformation, and AI & Data Strategy . Professionals will serve as trusted ... growth and enterprise value. We are hiring an AI/ML Data Engineering Lead to support the design,...engaging with internal stakeholders, understanding business priorities, defining the data strategy , and leading application deployment in… more
