- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...study team level including recommendations for and review of data outputs for collection of specific data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and ... areas/ SAP Finance modules: Asset Management, General Ledger, Travel Management, Master Data , Procure to Pay, Invoice to Pay, Project Systems, Taxes, Vertex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across...either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in class sourcing and procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as ... knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... reuse. Maintains detailed Solution Architecture diagrams for ALL systems, integrations, and data flows. Work with the Enterprise Architecture team to ensure all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with internal ... statistical programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that knowledge preferredTechnical knowledge of modeling tools (eg Excel) and data sources (eg Symphony, IQVIA) preferredSufficient understanding of financial matters ... to challenge and pressure-test assumptions (eg pricing, GTN, etc) preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education: ... Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the category strategies. Proactively uncovers insights and value from all Category data to identify new areas of opportunity for additional sourcing value and ... helps influence and inform budgeting decisions by the Business and the utilization of suppliers.- Serve as the Project Management Owner for DSI's overall Supplier Relationship Management Program (SRM) with Tier 1 suppliers which includes robust comprehensive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Merck & Co. (Rahway, NJ)
- …to improve and save lives of women with breast and gynecological cancers. Associate Director Global Oncology Marketing Women's Cancer Portfolio Key ... working and governance teams (launch readiness reviews, identification of data gaps and approaches, organized customer interactions, market research, demand,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... of PV agreements, PV plans, and SMPs.Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal guidelines… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a dynamic and visionary leader for the role of Associate Director , Community Exchange Manager. This person will be responsible for ... building strong community relations related to digital, data , and analytics within HHDDA and across the Human Health organization. They will also drive cultural… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director - Immunology Competitive Intelligence Immunology Competitive Intelligence Associate DirectorUnder the ... . Partnering with key stakeholders, individual will benchmark competitor clinical data , business models and capabilities to develop insights and recommendations that… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, ... NJ. Assess real-world data gaps and lead evidence generation process for the...pharmaceutical industry experience in the job offered or as Associate Manager. Also requires 5 years of experience with/using… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
