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    Regulatory Data Lead - Boston, MA, United States - ProClinical

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    Description
    RWE Lead - Contract - Remote

    Proclinical is seeking a Real World Evidence (RWE) Lead who will provide clinical leadership for evidence generation activities, supporting the integration of RWE into key strategic initiatives.

    This is a remote contract position.

    This role functions in a matrix team environment, interacting with several key stakeholder groups including Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research, and Legal.

    MD with additional Epidemiology/Pharmacoepidemiology/Health Economics graduate education and experience in the pharmaceutical industry.
    Experience with medical monitoring and leading post-marketing studies.
    Proven RWE experience with claims, EHRs, and prospective data.
    Knowledge and experience with PROs and PRO data capture.
    Experience contributing to the design and implementation of natural history studies and registries in the pharmaceutical industry.
    Provide medical monitoring of observational studies.
    Contribute to publication development and other external scientific exchanges.
    Lead assessment, interpretation, and communication of relevant scientific literature.
    Maintain knowledge and skills on evolving epidemiological, health economics methods, tools, and data sources.

    Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


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