- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... 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)
- …checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Merck & Co. (Rahway, NJ)
- …and prepares , analy ze s , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Responsible and accountable ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our Company's Research Laboratories portfolio… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in the ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full of our Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study ... creation of SAE Flow Plans and may perform final review . This position provides input on electronic data capture...on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …at governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive ... Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, ... will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally and across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety… more
- Merck & Co. (Rahway, NJ)
- …Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid ... as relevant members to the Product Development sub-teams (Value Evidence, Clinical , Commercial, Publications and Label teams)Aligns medical plans and activities with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study ... Associate Manager within Clinical Operations, in adherence to the protocol, Good ...trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review and document CRO-generated reports, such as site monitoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position ... requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports ... PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts (eg development, license, distribution… more
- Merck & Co. (Rahway, NJ)
- …potential medical breakthroughs.Support statistical programming activities for Early Oncology clinical development projects. Review the quality and reliability of ... statistical analysis and high-quality data to support decision making in clinical trials.Responsible for the development and execution of statistical analysis and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical ... of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead ...CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview ... with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate… more
- Merck & Co. (Rahway, NJ)
- …to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our ... have a medical contact within the company.Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding… more
- Merck & Co. (Rahway, NJ)
- …stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for ... driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late-stage clinical ... management and to external party for the collaboration program. Participate in the review and analysis of quarterly financial results against plan and monitor key… more
