- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Manager of HCP Marketing will be a pivotal driver in shaping an insights-driven HCP ... market access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to ensure… 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
- 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...requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in… 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
- 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
- Lundbeck (Memphis, TN)
- …in order to be successful promoting our products to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion ... on customer needs and organizational goals, incorporating "total office" account management where applicable. Local Market & Therapeutic Area Expertise - Gather… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …usage, and disease-specific requirements to DM standards teams and program teams.- Advise Manager , Laboratory Data Management on complex textbook range and unit ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Genmab (NJ)
- …Manager will work with other functions including Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational Research, Medical Writing, ... innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid,...Project management , and Regulatory . Responsibilities/tasks - including but… more
- Eisai, Inc (Nutley, NJ)
- …drug development plans within the clinical development. Works with the clinical, project management , and data manager teams on strategic designs of studies; ... & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management ,… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of direct reports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...(ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and… more
- Genmab (NJ)
- …and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management , concise written communication, ability ... and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and… more
- Fallon Health (Worcester, MA)
- …follow us on Facebook, Twitter and LinkedIn. **Summary of purpose:** The Care Management (CM) Regulatory Manager is an essential function to Fallon ... and processes and CMS and EOHHS contract requirements. The Care Management (CM) Regulatory Manager serves as the expert on regulatory contract… more
- Abbott (Alameda, CA)
- …regulatory outcomes of initial product concepts and provide input to senior regulatory management . Provide strategic input and technical guidance on ... you can do work that matters, grow, and learn, care for yourself and family, be your true self...levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager ** will work on-site in… more
