- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... key markets (Required)2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and… more
- Genmab (NJ)
- …CollaborationCollaborate with Trial Management , Clinical Operations, Medical, Biomarker Management , Biostatistics, Medical Writing, and Regulatory Affairs to ... industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and inspection… more
- Genmab (NJ)
- …and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and ... but we have big ambitions, bring a ton of care to pursuing them, and have a lot of...are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our… more
- Eisai, Inc (NJ)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT...and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and… more
- Merck & Co. (Rahway, NJ)
- … Management , Process Optimization, Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk ... the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of… more
- Genmab (NJ)
- …the programming efforts of at least one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical ... innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid,...we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference ... to join our team as a Director of Program Management and Execution Excellence. We are looking for a...Execution Excellence. We are looking for a season Program manager with a passion for driving impactful business outcomes… more
- Merck & Co. (Rahway, NJ)
- …Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to… more
