- Daiichi Sankyo, Inc. (Bernards, NJ)
- …representative with key high-level internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead. Responsible ... to support all projects and maintain business continuity.Managing productive cross-functional Medical Safety collaborations within and across line functions, eg… more
- Taiho Oncology (Philadelphia, PA)
- …Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical ... Medical Science Liaison Philadelphia, PA, USA Virtual Req...PA, Upstate NY, DC, MD, DE Position Summary: The Medical Science Liaison (MSL) is a field-facing representative of… more
- Insmed Incorporated (San Diego, CA)
- …provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety , and quality assurance teams, as well ... monitoring, and query resolutionWork with other clinical scientist(s), medical monitors, and drug safety to provide support and scientific review of safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of projects concurrently. Additionally, this position possesses working knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, ... dictionaries) including dictionary support documentation. Collaborates cross-functionally with the Medical , Clinical Development, Clinical Scientists, Clinical Safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review Plan (IDRP)Accountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Associate Director. Interacts with colleagues within Patient Support Programs, Patient Safety , Quality, NNI IT and Telephony, Medical Information, Compliance, ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position oversees the creation of SAE Flow Plans and may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange… 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 ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the ... understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.The … more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility ... development team. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing/facilitating, maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs, Patient Safety required A ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...execution of CMR role-specific/technical training (eg clinical trial-related, patient safety , therapeutic area leads, MSLs etc.) across the US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that… more
- Genmab (NJ)
- …review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis Provide medical input for country/site ... of all aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high-quality and timely… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with standard operating procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health ... and implement key Plant projects and initiatives.Ensures adherence to company safety standards, policies, and procedures. Ensures maintenance staff and contractors… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Utilize big data to analyze the safety and efficacy claims of potential medical breakthroughs.Support statistical programming ... development and execution of statistical analysis and reporting deliverables (eg, safety and efficacy analysis datasets, tables, listings, figures) for early… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team that supports daily production of a CAR-T manufacturing facility.Maintains safety standards and training in the department; ensures that the building ... in a clean and safe manner which includes performing monthly operational/ safety inspections Supervises maintenance personnel to ensure all corrective and preventive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to HCP/KOL Strategy Lead. Collaborates closely with sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and ... guidelines, and best practices in patient care Scientific Expertise: Translate complex medical data into clear, concise information / content for HCPs, bridging the… more
- Merck & Co. (Rahway, NJ)
- …facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.Our team in Rahway, New Jersey, is seeking an exceptional ... enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable… more
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