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Medical & Regulatory Clearance Partner

Company: Roche
Location: Indianapolis
Posted on: August 7, 2022

Job Description:

The Medical & Regulatory Clearance Partner ensures the Good Promotional Practice (GPP) for Roche Diabetes Care products and solutions. The GPP activities guarantee that the information communicated externally is in alignment with the existing medical/scientific evidence and compliant with the local regulation. This is especially important in the medical device industry, where health authority regulators are looking for products to be promoted on-label, and according to their classification, to guide health care professionals and patients making informed decisions. As a Medical & Regulatory Clearance Partner, you will be responsible to interact with several departments and ensure that there are processes in place for GPP activities.Key Responsibilities:To perform GPP activities, you will need to work closely with the following other departments:

  • Medical & Scientific Affairs - to ensure the medical and scientific accuracy regarding the efficacy and safety of products in all promotional activities
  • Regulatory Affairs - to ensure the product intended uses & indications are aligned with label and with other local regulatory requirements.
  • Compliance Officer - to ensure that activities such as research studies and product donations are being done in an ethical & compliant manner, and aligned with internal SOPs
  • Quality Area - to stay informed of audits and changing Quality Management System requirements; as well as to partner with for audits & surveillance reviews
  • Legal Department - to work together on issues and to stay informed of legal risks (relating to regulatory risk)The Marketing organization is your primary stakeholder. You will guide and support them in the following ways:
    • Advise campaigns and product claims
    • Approve all external sales, marketing, scientific, information, and product training materials
    • Own all Good Promotional Practices procedures policies, processes; as well as some for product labeling
    • Review & approve all product labeling & manual updates
    • Lead audits & surveillance reviews of related GPP processes
    • Support non-conformances & CAPAs related to GPP
    • Lead Regulatory Opinions for promotional activities (e.g. product claims) related to current and future products
    • Represent GPP interests during discussions with external stakeholdersGenerally, you must be a professional with wide-ranging skills to interact with multiple departments. You will deal with diverse and complex issues, where analysis may require in-depth evaluation of many factors. You would also network with internal and external personnel of different areas and expertise.Requirements
      • Bachelor's degree in Health Care is preferred
      • 3 years of experience working in an FDA-regulated industryPreferred
        • Experience working in the medical device & in vitro diagnostic products field
        • Previous experience or knowledge of Good Promotional PracticesWho we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

Keywords: Roche, Indianapolis , Medical & Regulatory Clearance Partner, Healthcare , Indianapolis, Indiana

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