- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... of a single or multiple clinical trials from strategy outline through to CSR by...outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical … more
- Merck & Co. (Rahway, NJ)
- …that delivers high quality data and clinical supplies. This position reports to the Associate Director of Global Clinical Supplies Quality and is ... critical to maintaining the global clinical supply chain via related disposition activities for clinical finished goods provided by our Company for worldwide… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work ... Operations Department that manages multiple early to late-stage clinical programs. The Associate Director ...as a Clinical Trial Manager Experience with global clinical trial operations, in multiple phases… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …6+ years, MS with 8+ years, or BS with 10+ years of relevant global safety surveillance and/or clinical /drug development experience required Excellent verbal and ... About the Department Our East Coast Global Development Hub brings together the best minds...NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... 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)
- …diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting will drive creation of ... demand and revenue forecasts. The Associate Director is a dynamic member of the Global...forecasts of inline brands and assets / indications in clinical development.- Support commercial assessment of Early-Stage assets for… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be ... a part of our Global Regulatory Affairs organization.In this role, you will work...Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include ... 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
- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight ... be our best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible for the oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on… more
- Merck & Co. (Rahway, NJ)
- … Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality Assurance is responsible for ... Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance.… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director of US Medical Affairs Solid Tumors Strategy will report to ... the Director , US Medical Affairs Solid Tumors Strategy Lead. S/he...the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead...These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently seeking an Oncology Competitive Intelligence Associate Director . This role is responsible for providing Competitive Intelligence ... insights, benchmarking, and recommendations for commercialization strategies, portfolio prioritization, clinical development/research strategies, and Business Development initiatives.Analyzing select competitor… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within the Global … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter expert in CDISC Controlled Terminology ... growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data governance… more
- Merck & Co. (Rahway, NJ)
- …management.Develop American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package in close ... products. Serve as outcomes research representative on cross-functional regional and global teams.Critically assess drivers and barriers to reimbursement and market… more
