- 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 ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Abbott (Minneapolis, MN)
- …location for our Electrophysiology division. As a manager , the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory ... and get on with their lives. The Opportunity The Regulatory Affairs Manager will work on-site at...outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- Merck & Co. (North Wales, PA)
- …specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Science {+ 4… more
- Aequor (Thousand Oaks, CA)
- …/hour Urgent role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's ... reliable patient supply. With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions… more
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- King and Spalding LLP (Washington, DC)
- …a leading global law firm, seeks a driven and experienced Business Development Manager to support the Regulatory and Investigations Practices. The role works ... and approachable demeanor, with comfort and competence both in dealing with senior lawyers and working collaboratively with other lawyers and business services… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, ... ensure appropriate operational execution. Relationships This position reports to the Sr Director, Patient and Consumer Insights. Other key relationships include… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists The Opportunity We are seeking a Regulatory Affairs Manager to join Abbott's Heart Failure Division on-site in ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...meetings; Work with cross-functional teams. Clearly explain and articulate Regulatory plans to Senior leaders. Cognitive Skills:… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... science through compelling clinical and regulatory documents. You'll be at the heart of a...experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should also have knowledge of Health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements ... plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and...the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency… more
- Merck & Co. (North Wales, PA)
- …execution elements (eg operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Arkema (Broomall, PA)
- … regulatory issues pertaining to each BU and its products. (5%) Support Manager , Product Stewardship & Regulatory Affairs in efforts to effectively manage and ... activities to assure compliance with legal and corporate product stewardship and regulatory affairs requirements in a cost effective and efficient manner. This… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
