- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), ... for post-doctoral fellows. Provides guidance, and mentors and coaches junior Clinical Safety Scientists.Responsibilities Risk Management (Signal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice and ... this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... of experience with Supplier Management , Research Administration, Grant Operations, Grant Management , clinical trial management , or a similar research… more
- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-… more
- Genmab (Plainsboro, NJ)
- …leading all major pre- and post-marketing safety related deliverables including signal, benefit- risk evaluation, and risk management activities. This ... Head of Global Drug Safety & PV, the Senior Director , Global Drug Safety & Pharmacovigilance Physician serves as...preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders. The ability… more
- Merck & Co. (North Wales, PA)
- …focused on improving patient careManages regional programs (patient support, educational or risk management ) to support appropriate and safe utilization of the ... help people with cancer across the globe.The Regional Associate Director of Medical Affairs - Gastrointestinal Cancer (RADMA) position...with the Upper GI and Lower GI US Regional Director of Medical Affairs (RDMAs) and partner with regional… more
- Merck & Co. (Rahway, NJ)
- …commercialization.Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control ... and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tailored for AEs from end-to-end: understanding predisposing non- clinical and clinical factors, diagnosis, effective management during clinical trials ... of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout...remains top of mind in the context of patient management in the clinical trial setting and… more
- Merck & Co. (Rahway, NJ)
- …and leadership skills.Project management experience including resource management , budget forecasting, and risk assessment/mitigation planning.Comfort with ... Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance...& Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-… more
- Novo Nordisk Inc. (Boulder, CO)
- …all departments, such as Quality Assurance/ Control, Chemical Development, Program Management , Regulatory, Quality Control, Supply Chain, and Clinical Write, ... The Manager of Drug Product Manufacturing is accountable for clinical phase 1 and 2 drug product manufacturing and...to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies… more
- Merck & Co. (North Wales, PA)
- …the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations within our Research & ... Laboratories drive break-through science through drug discovery, development, and clinical evaluation to address the significant unmet medical needs.-Finance is… more
- University of Washington (Seattle, WA)
- …locations such as Harborview Medical Center as needed. This position reports to the Associate Director , Clinical Risk Management , for UWMC, and to the ... Req #: 233903 Department: UW MEDICINE CLINICAL RISK MANAGEMENT Job...Associate Director , Clinical Risk Manager for Harborview Medical Center… more
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