- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... 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)
- …15 E- Maintains detailed Solution Architecture diagrams for ALL systems, integrations, and data flows. Work with the Enterprise Architecture team to ensure all ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Data Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating with ... Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo ... Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management. Lead the creation of the CRO scope of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...program operations and technology systems. This position will also lead the development of operational business plans to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the ... (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections in the US, in collaboration with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional ... assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in...and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to ... development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research...our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure alignment of HCP brand objectives, KOL engagements, and strategies. The HCP - Strategy Lead (MASH) has a team of HCP and KOL strategists reporting to ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Data Management Plan, and dictionary coding synonym list. Coordinate with Data Operations Team on coding dictionary set up, registration of dictionaries, ... medical terminology concepts and industry standards and technical skills in coding data received from CROs and vendors. This position requires solid verbal/written… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting planning and… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs...field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... CRO CRA monitoring oversight and share findings with appropriate stakeholders/ team leadership.Collaborate on the development of monitoring plan templates including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and ... stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk… more
- Merck & Co. (Rahway, NJ)
- …include: Lead the development of communication strategies grounded in data insights, ensuring all corporate messaging and engagement initiatives align with ... DescriptionThe Director, Insights & Analytics is responsible for leveraging data -driven insights and advanced analytics to shape communication strategies, enhance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
