- 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
- 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
- Citigroup, Inc. (Tampa, FL)
- The Regulatory Reporting Manager -Securites Services accomplishes results through the management of small professional team(s) and department(s) or as an ... analytics, information management across Investor Services products and reports to senior management. Responsible for communicating to Regulatory Reporting… 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
- 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
- Central Garden & Pet (Dallas, TX)
- …and has an exciting opportunity for a skilled and experienced Food Safety and Regulatory Affairs (FSRA) Manager to join our team! This position reports to ... the Sr . Director, FDA Regulatory Affairs & Food...procedures/policies, etc.; and, other duties as required/requested by the Senior Director, FDA Regulatory Affairs & Food… 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
- 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
- EPM Scientific (San Diego, CA)
- Title: Senior Specialist/ Manager of Regulatory Affairs Summary: A global leader in medical technology is seeking an experienced and driven Regulatory ... outcomes, and this role offers the opportunity to contribute to shaping regulatory strategies and supporting groundbreaking product development. If you have strong… more
- Mondelez International (Richmond, VA)
- …to Lead the Future of Snacking. Make It With Pride. The Quality and Regulatory Compliance Manager ensures effective deployment of MDLZ risk-based Food Safety ... to ensure products made at the Richmond Bakery meet regulatory and Mondelez' requirements for Food Safety and Quality....and advice on risk management interactions with authorities, Plant Sr . Quality and Food Safety Manager and… 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
- Genmab (NJ)
- …the above by developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as a compound lead.Responsibilities/tasks ... for Programming Manager , at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in both written and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships ... Responsible for the compilation and processing of pharmacy redemptions for Senior Management approval Oversees vendor performance via regular status meetings,… more
