- Merck & Co. (North Wales, PA)
- …at the site level. The GTO outputs for which a GTOS is responsible drive Clinical supply planning, timing and feasibility assessment of clinical programs and ... experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF ... Director, Clinical Development Join a Legacy of Innovation 125...review per Integrated Data Review Plan (IDRP)Accountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers… more
- Rush University (Chicago, IL)
- …care for complex patients based on knowledge acquired from previous clinical experiences. 15.Utilizes competent assessment skills to holistically evaluate ... care continuum. 6.Utilizes evidence-based ambulatory care nursing interventions during clinical visits, telephone encounters, and electronic communications according to… 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...governance, functional area experts and development review committees.Contribute to assessment of internal and external opportunities identified by Business… 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 ... product development for small molecules and/or biologics, conducting hypothesis-based assessment employing a rigorous integrated approach, driving the development of… more
- Aequor (South San Francisco, CA)
- …underlying toxicities that are observed non-clinically and / or in clinical trials through hypothesis driven research. This process involves closely collaborating ... with scientists across the organization to support the overall safety assessment for our Client therapeutics spanning drug discovery through clinical development… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data between partners in relation to marketed and clinical products.Strategic Partner Management:Oversees Local/Global PV service providers responsible for ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings… more
- Merck & Co. (North Wales, PA)
- …GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical ... Division Serve as an expert on informed consent policy and lead assessment /implementation of policy changes while integrating health literacy, and health equity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes ... and preventive actions, as necessary.Supports internal/external audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the Floor… more
- Merck & Co. (Rahway, NJ)
- …cross functional team including marketing and Product Development Teams (PDTs), (ex. clinical , OR and medical affairs), regional and country teams to ensure patient ... access objectives and strategy are linked to clinical development, commercial and value evidence plans.In partnership with global and regional and country access… more
- Merck & Co. (North Wales, PA)
- …research including design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic ... and identifies value evidence needs to provide strategic input into clinical and market development programs.-Develops the integrated evidence strategy including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the therapy area/brand value story and positioning to maximize launch through clinical evidence, and an in-depth understanding of the competitive landscape, market ... Market and Customer Experience Mapping Facilitate TA market analysis, competitor assessment , market sizing, and customer experience insights to shape strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner ... risk problems, providing guidance to leadership including trade-off and implications assessment (value, risk, cost, time) to the project or programPrepares and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and subject matter expertise. Provide risk analysis, business and technical assessment of requests in relation to data platforms.- Continuously evaluate new ... Supply Chain, Finance and HR preferred- 1 or More Years Experience with Clinical Trials Data, Genomics and Bio Marker Data, Real World Data, Discovery Data… more
- Aequor (Bothell, WA)
- …processes for recombinant proteins and biological macromolecules for early- and late-phase clinical trials. The responsibilities of this position include but are not ... Support process development for new molecules from platform process fit assessment through IND submissions Transfer manufacturing processes to internal and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom ... system topics, in both classroom setting and individual interactionsSupport the creation, assessment and closure as needed of corrective actions, change controls, or… more
- Merck & Co. (Rahway, NJ)
- …communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards ... development and implementation of proactive risk management strategies, including risk assessment , risk mitigation, and risk communication, to ensure the ongoing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …optimizing the impact of Consumer support programs. Support in the ongoing assessment of the evolving brand/therapy area competitive landscape to develop innovative ... Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within specified therapy area… more
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