- Novo Nordisk Inc. (Plainsboro, NJ)
- …Interacts with colleagues within Patient Support Programs, Patient Safety , Quality , NNI IT and Telephony, Medical Information, Compliance, Regulatory, Legal ... us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects...responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.SummaryThe Director, Clinical Safety , will be a product safety lead or part of a product safety team, and be ... coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.Coordinate and… more
- Novo Nordisk Inc. (Durham, NC)
- …Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …DMCs, and Academia. L ine management responsibility of Director/Associate Director Global Safety Lead , Senior Global Safety Scientist(s)/Global Safety ... Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Genmab (Plainsboro, NJ)
- …clinical trials, medical review and communication of data, and medical input into regulatory documents and presentations.Responsibilities: Lead the ... in the development of the clinical development plan (CDP). Lead creation and review of clinical components of key...clinical studies and signal detection with support of the Safety physician Create, integrate, and execute overall medical… 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, ... change management, and risk management.Responsibilities:Leadership, Direction, and Strategy:Responsible for medical coding deliverables for assigned programs meeting quality… more
- Insmed Incorporated (San Diego, CA)
- …of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key ... primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies. Medical monitoring, coding, and data… 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...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process improvement, metrics design and application and other key drivers of enhanced quality .Aligns with the RBQM Risk Management Lead on critical-to- quality ... risk, quality tolerance limit (QTL) libraries, and critical-to- quality factors. Lead RBQM Center of Excellence for...process improvement initiatives related to RBQM CSM to improve quality and ensure patient safety and data… more
- Merck & Co. (Durham, NC)
- …SME during tours to provide area/process overview information to visitors/auditors upon request. Quality & Safety Compliance Foster strong safety culture on ... order to resolve process/equipment issues, minimize downtime, and ensure product quality .This role will support activities for manufacturing operations areas for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment Categorization Tool (RACT) Ensure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos that ... personnel. Additionally, you will implement testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with standard operating procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and ... Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... commercial functions (Sales, Marketing Operations, Market Access, Pricing & Contract Ops, Medical , Legal) as well as global market research and brand teams. Drive… more
- Merck & Co. (Rahway, NJ)
- …that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be ... robust scientific methodology we collaborate to discover the next medical breakthrough.Our team in Rahway, New Jersey, is seeking...of and hands-on work in applying regulatory guidance and quality standards related to product release and safety… more
