- Insmed Incorporated (San Diego, CA)
- …internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to ... planning through final reporting of results Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… more
- Merck & Co. (North Wales, PA)
- …experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods ... and for recruitment and retention of patients in our clinical trials. Participates in early identification of potential risks...with support from GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational… more
- 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)
- …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
- 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
- Genmab (NJ)
- …Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely ... delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management… more
- Insmed Incorporated (San Diego, CA)
- …medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data, ... and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Clinical Research Associate will support the Clinical Research team in literature searches, document generation, editorial review , and ... organization as well as assist with laboratory experiments as needed. Job Responsibilities Develop an understanding of the drug development processes within ExelaGain familiarity with product specific literature searches to gather and present information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is...and presentation. Demonstrate an ability to perform medical accuracy review with strong attention to detail. Proficiency in Microsoft… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to ... plan for on-site and remote site visits (expectations of staff contact, ISF review , IP review , SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit… 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)
- …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
- Merck & Co. (South San Francisco, CA)
- …Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery ... Sciences and late-stage Clinical Research. We work with all therapeutic areas within...to therapeutic area governance, functional area experts and development review committees.Contribute to assessment of internal and external opportunities… more
- Genmab (Plainsboro, NJ)
- …in the conduct of clinical trials in oncology. Proficiency in clinical data review and interpretation.Solid experience in translating medical/ clinical ... market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and other cross functional teams.We have a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial-related, GxP, Compliance, etc.) across the US and Canada… more
- Taiho Oncology (Philadelphia, PA)
- …on Taiho products and relevant disease states, and facilitation of clinical research. The MSL integrates clinical /scientific expertise and knowledge ... Product/Therapeutic Area Support to External Stakeholders: Act as the primary clinical /scientific resource to HCPs in a specified geography for information… 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
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