- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary The Director , Head of Global Dossier Planning , Regulatory Operations is responsible for leading the dossier planning ... major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions...in all regions. The Director of Dossier Planning will report to Head of Global Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicableStudy planning and execution: As CSL ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and risk management activities for assigned product(s), including resource planning , oversees team's workload, anticipates potential issues and works towards ... cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... programsThe CS group lead will also contribute to the program study strategy, planning , execution, and reporting outputs in collaboration with the CS Asset LeadsThe… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …presentation, meeting agenda and meeting minutes.- May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth ... knowledge of regulatory authority's requirementsTypically has administrative responsibility for recruiting, retaining,...support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining,...support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... planning , review Case Report Form (CRF) annotation and SDTM...quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma?Then you could be our new Global Marketing Director , InLine Dx, Precision Medicine. The position: -We are currently recruiting for ... a Global Marketing Director , InLine Dx, Precision Medicine within Oncology Global Marketing....and Regional Marketing OrganizationsShort & long-range Business Strategy & Planning ; development of diagnostic commercial strategies and tactical plans,… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...launch.- The successful candidate will be responsible for resourcing planning , risk assessment strategies, talent development, and partnering to… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… more
- Merck & Co. (Rahway, NJ)
- …and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic ... robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage user access and… more
- Merck & Co. (Rahway, NJ)
- …highly desired. Areas of expertise should include but not limited to- Planning , Warehousing and Distribution and cross functional knowledge of Production Execution, ... gathering functional / business requirements for solution design for planning , warehouse operations, distribution, ensuring compliance with market requirements as… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI) ... the identification and prioritization of intelligence efforts critical to strategic planning and execution for key stakeholders and will provide direction for… more
