- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or a life sciences/pharmacy nursing degree with 15+ years' experience in global safety surveillance and/or clinical/ drug development Excellent verbal ... the US East Coast Development Hub comprised of Senior Global Safety Leads, Global ...external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development… more
- Merck & Co. (Rahway, NJ)
- …drugs Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of professional management experience in PV required- 10+ years of Drug Safety /Pharmacovigilance experience, including both investigational and marketed products ... DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety ...required- Knowledge of Adverse Event and drug coding conventions (MedDRA, WHO-DD)- Knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization… more
- Genmab (Plainsboro, NJ)
- …the CSR Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of ... best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of… more
- Genmab (Plainsboro, NJ)
- …part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US ... and content expert for internal and external stakeholders, representing Genmab at key Global and US medical conferences, at US advisory boards and at internal… 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 ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …toxicology studiesProcess and analyze tumor and tissues samples from mice and NHPAssess safety and tox risks of cell-based drug productsAnalyze, document and ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma.Legend Biotech is seeking Associate Director of In Vivo Pharmacology as part of the… more
- Merck & Co. (Rahway, NJ)
- …drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and… more
- West Pharmaceutical Services (Exton, PA)
- Director , Global Supply Planning, Drug Delivery...the set target + Able to comply with the company's safety policy at all times + Able to comply with ... a healthier environment and planet through our sustainability efforts. **Job Summary:** The Director , Global Supply Chain Operations has the end-to-end global… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in… more
- Teleflex (Morrisville, NC)
- Associate Global Medical Safety Director (Part Time/Remote US) **Date:** Nov 27, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected ... global Teleflex portfolio reporting directly to the Global Medical Safety Director . As...position will also include benefits such as medical, prescription drug , dental and vision insurance, flexible spending accounts, participation… more
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety ...+ Accredited MD/DO (MBBS, MBCHb, MBBCh) + 5+ years drug safety experience in a biotech or ... PV activities. This individual has a solid understanding of global PV regulations and maintains oversight of safety...pharmaceutical company + Ability to drive drug safety evidence generation and risk mitigation… more
- Amgen (Washington, DC)
- …for a career you can be proud of. ** Global Safety Officer (GSO),** ** Global Safety Medical Director - Oncology** **, US - Remote** **Live** **What ... lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be...statistical analysis plans, and clinical study reports + Prepare/review safety sections of new drug applications and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pathology Drug Safety Research and Evaluation (DSRE), Head of ... DSRE, Pathology team, you will report to the Senior Director DSRE - Pathology and you will partner with...project teams, Global Head of Pathology and Drug Safety Therapeutic Area Leaders in the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs, Global Patient Safety , and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs, Global Patient Safety , and Development Quality (RA,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening diseases. **Senior Director , Human Resources Business Partner, Global Patient Safety ** We are seeking an experienced business and ... as **Senior Director ** , **Human Resources** **Business Partner** supporting the Global Patient Safety (GPS) organization. This individual will act as a… more
- Emory Healthcare/Emory University (Decatur, GA)
- …directs the Focus Area for Compassion and Ethics (FACE) program at the Task Force for Global Health (TFGH). The Director of FACE serves as the lead for the ... FACE helps to address important gaps and challenges in global health, including in mass drug administration,...symposia, conferences, and working groups on topics related to global health ethics and compassion. The Director … more
