- 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
- 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
- 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, ... other documentation to assist with audits and inspections, both internal and by regulatory authorities Design, develop and manage tools which are being used to… 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
- 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to end ... teams both as a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior cross-functional leadership in… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and ... Board of Pharmacies for state licensing submissions. Provide regulatory guidance to R&, D, Technical Operations Sales and Marketing, Quality, Clinical, Legal.… more
- BURNCO LLC (Henderson, CO)
- …business acumen and exceptional relationship-building abilities? BURNCO is seeking a General Manager to lead our Ready-Mix division in Colorado. Join us in building ... Build and maintain strong relationships with community stakeholders, industry partners, and senior customers Develop, lead, and collaborate with the HSE team to… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... (written and verbal).-Ability to effectively influence key stakeholder groups (including senior and executive levels of an organization).-- Integrity - Stewardship… more
- Ascension (Wichita, KS)
- …workflow and resources of assigned nursing travelers. Ensure compliance with regulatory and accreditation requirements for their assigned team. Identify and resolve ... required. Additional Preferences previous RN experience in NICU previous manager experience #ATP Why Join Our Team Ascension associates...of care, including more than 140 hospitals and 40 senior living communities in 19 states. Our Mission, Vision… 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
