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Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
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The Director will develop collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development, Advocacy, Commercial and Market Access) as well as external medical experts and will have an integral role in driving the planning and execution of scientific communications deliverables across the Insmed respiratory franchise.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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Interact with Regional Market Access/Health Economics / Outcomes Research and Medical Affairs teams to coordinate and develop real world evidence generation in support of their access programs.
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Under the direction of the Cash Manager and the Cash Management Supervisor, the Treasury Analyst assists in managing the mobilization and flows of daily cash, including especially controlling external accounts, handling domestic and foreign wires, and settling Securities.
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Foster collaboration, alignment and seamless working across R&D and GCSO functions, including the Clinical Development Team (CDT), Commercial, Medical Affairs, and Global Market Access COE to ensure optimal launch readiness for the brand.
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This role will develop and lead all medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications) all key Medical Affairs functions (Medical Excellence, HEOR, Field Medical, Medical Information) as well as maintaining a high-level cross-functional collaboration across the organization to ensure alignment and One Insmed approach.
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He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Description SummaryThe Treasury Manager is responsible for cash management, cash flow forecasting, preparing, and executing monthly quarterly and daily intercompany funds flow schedule, foreign exchange management, monthly and quarterly reporting requirements for Treasurer, accounting, and external reporting and ad-hoc project work to support on-going business objectives and assist with debt compliance and capital allocation strategy.
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They are at the forefront of life sciences and biomedical engineering, robotics and automation, artificial intelligence, machine learning, photonics, computers, software, hardware and chip design, microwave theory, aeronautics, the Internet of Things, cellular communications, power and energy, remote sensing, and cybersecurity, among other cutting- edge technologies.
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It is the Credit Specialist's responsibility to know their accounts and any reasons they are not paying and to be able to communicate effectively with both internal and external business partners to resolve any issues that may arise.
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Engage in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA)Manage customized bioanalytical assays via network of external service providers in advance of and during clinical development.
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Continuous innovation in passive component function integration, miniaturization, and manufacturing automation, cutting edge WSS and amplifier technology and comprehensive optical, mechanical, electrical and software integration capabilities enable us to serve the needs of high-density, high-bandwidth, and flexible optical networks.
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Develop relationships with customers in target markets and work with internal & external resources/partners to deliver formulated solutions and technical information to support customer projects globally.
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The Transfer Center Dispatcher serves as a liaison between both internal and external customers as well as providing ongoing support to the hospitals to implement their throughput plan(s). After onboarding, this position must be proficient in running ABOUT’s Transfer Center technology, Five9 phone systems with call recording, EPIC including creating Reservation for transferred patients and office-oriented systems as required supporting client operations.
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edge external affairs jobs Company: Capital One in Bridgewater, NJ
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