Jobs
>
Summit

    Sr. Manager, Real World Evidence - Summit, United States - Saviance Technologies

    Saviance Technologies
    Saviance Technologies Summit, United States

    1 week ago

    Default job background
    Description

    This position provides technical leadership on Phase IV research support to the Global Lead, Center for Outcomes Research and Evaluation (CORE) within Medical Affairs in the strategic development, coordination and execution of RWE generation activities.

    Such activities include, but are not limited to, the development of strategic Phase IV research plans supporting key brand imperatives, the design of methodologically sound Phase IV study protocols to meet project objectives as well as the initiation and support of Seqirus-led, collaborative and sponsored research programs to ensure quality, time and budget deliverables are met.

    This position is also responsible for managing the supporting research staff, including direct reports and third party service providers.


    A key function of this role is to lead the design and execution of Phase IV studies to generate real world evidence related to disease natural history, burden of disease, immunization-related coverage patterns, and other key behavioral factors.


    This position is responsible for establishing and maintaining collaborative relationships with leading authorities, academic institutions and government entities focused on influenza vaccine Phase IV research.

    Ultimately, this position supports the development of outcomes research that lead to peer-reviewed scientific publications and reimbursement dossier development.


    This position is also responsible for participating in cross-functional discussions supporting the publication of CORE research through internal-facing education initiatives within Medical Affairs.


    Responsibilities:
    Assure regulatory compliance with internal procedures and external standards.

    Submit documents to regulatory agencies, including regulatory agencies; assists with communication, negotiations and follow-up deliverables

    Establish and maintain policies, guidelines, and procedures for the regulatory affairs department

    Provide regulatory support on product development and project teams

    Provide regulatory assessments for manufacturing design changes and validation activities

    Review and approve test protocols to support regulatory submissions

    Ensure product launches and distribution complies with applicable regulations

    Provide regulatory input in quality management system, assessments, product development and compliance


  • Moderna Princeton, United States

    **The Role**: · Moderna is looking for a Manager, Real-World Evidence Analytics in Princeton, New Jersey. This role involves collaboration across various teams to generate real-world evidence for drug effectiveness and disease insights using diverse data sources such as claims an ...


  • Rocket Pharmaceuticals Cranbury, United States

    Rocket Pharmaceuticals · Director Real World Evidence · About the job · Work at ROCKET PHARMA and help cure rare diseases · Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket pl ...


  • Johnson & Johnson Somerville, United States

    Job Description · Johnson & Johnson Innovative Medicine is recruiting a Manager, Global Real World Evidence, Hematology, located in Raritan, NJ . · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where ...


  • Genmab Princeton, United States Freelance

    Job Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...


  • Moderna Theraputics Princeton, United States

    The Role: · Moderna is looking for a Manager, Real-World Evidence Analytics in Princeton, New Jersey. This role involves collaboration across various teams to generate real-world evidence for drug effectiveness and disease insights using diverse data sources such as claims and e ...


  • Genmab A/S Princeton, United States Freelance

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...


  • Genmab Princeton, United States Freelance

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...


  • Genmab Princeton, United States Freelance

    Job Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...


  • Luminary Group New York, United States

    Job Description · Job DescriptionLuminary Group is currently seeking a highly strategic and experienced Chief Operating Officer (COO) with a strong background in Real World Evidence (RWE) and previous experience working with private equity-backed companies. As the COO, you will p ...


  • Genmab Princeton, United States

    Job Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...


  • GENMAB A/S Princeton, United States

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...


  • AstraZeneca New York, United States

    Elevate Patient Safety at AstraZeneca with Real World Data Expertise · AstraZeneca seeks a forward-thinking Real World Evidence (RWE) Associate Director to join our dynamic Safety Analytics team within Global Patient Safety. This role is crucial in revolutionizing our approach to ...


  • Genmab Princeton, NJ, United States

    Job Description At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people w ...


  • Genmab Princeton, United States Full time

    The Role · This position will be responsible for developing and executing robust health economics, outcomes research, epidemiology and real-world evidence plans for a leading pipeline product (oncology) in alignment with brand strategies, medical affairs strategies, clinical deve ...


  • GENMAB A/S Princeton, United States

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...


  • Genmab Princeton, United States

    Job Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...


  • Genmab Princeton, NJ, United States

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...


  • Genmab Princeton, NJ, United States

    Job Description At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people w ...

  • Little Learner Children's Academy

    Daycare Teacher

    2 weeks ago


    Little Learner Children's Academy Plainfield, United States

    Little Learner Children's Academy is a privately-owned childcare center. Our core values are Family, Kindness, Patience, Customer Experience, Fun, Culture of Excellence, and Trust. We have a tight-knit team of early childhood professionals, and we want to hire YOU to join our tea ...


  • Little Learner Children's Academy Plainfield, United States

    **Little Learner Children's Academy** is a privately-owned childcare center.** Our core values are Family, Kindness, Patience, Customer Experience, Fun, Culture of Excellence, and Trust. We have a tight-knit team of early childhood professionals, and we want to hire YOU to join o ...