- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a dynamic and experienced IT Infrastructure Lead to join our team . This is an exciting opportunity to contribute to our company's ... mission of delivering innovative health solutions. As part of our team , you will have the chance to work in a stimulating environment that values teamwork,… 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
- 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...the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable 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)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …need for efficient, reusable, and user-friendly technology solutions. The Enterprise Architecture (EA) team is helping to lead this transformation. Our vision is ... decision-making that connects investments and achieved business results. This focus allows the team to be a crucial supporting partner with the business to help them… more
- Merck & Co. (Rahway, NJ)
- …Lead and operate within a cross-functional process development team .Preferred Experience and Skills:Experience with drying process development, optimization, and ... is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision… 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)
- …under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. ... Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings,… 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
- Merck & Co. (Rahway, NJ)
- …and execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate ... key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They collaborate with...guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative) such as clinical development,… more
- Merck & Co. (Rahway, NJ)
- …with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the data into analysis/modeling datasets, and ... analyses. The Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This ... and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design ... teams, building talent, and shown to be able to motivate, influence scientific team ; lead by example through past scientific / technical expertise).Experience in… more
- Merck & Co. (Rahway, NJ)
- …efficiencies that-will-inform investment decisions. The Portfolio Manager reports to the Value Team Portfolio Lead and works closely with Product Line ... Team .-Validation and prioritization of new portfolio demand in partnership with Value Team Leader & Portfolio Lead while instilling a culture of sharing and… more
