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Senior Manager, Medical Communications/Medical Information

Company: Evofem Biosciences
Location: San Diego
Posted on: October 22, 2019

Job Description:

Evofem Biosciences, Inc., (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem Biosciences exists to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). The Company is leveraging its proprietary Multi-purpose Vaginal pH Regulator--- (MVP-R) platform to develop AMPHORA--, which if approved will be the first on-demand and female controlled MVP-R birth control method in the U.S. We are a growing 40+ person team based in San Diego, CA. Our sole purpose is also our soul purpose: to improve the lives of women. We are committed to discovering and developing innovative healthcare solutions that put women first.
Senior Manager, Medical Communications/Medical Information
Job Summary: The Senior Manager, Medical Communications/Medical Information (SMMCI) is a scientific data and disease state expert in the Women's Health therapeutic areas of interest. Through the creation of evidence-based, balanced standard response letters (SRLs), frequently asked questions (FAQs), and managed care responses, the SMMCI will support the appropriate use of Evofem products by the medical community. The SMMCI will provide accurate and detailed medical reviews of US Commercial Marketing, Promotional, and Medical materials, in compliance with US regulatory requirements. The SMMCI will be the primary contact for the external call center and seen as the expert consultant on responses, database analysis and interpretation of information. The SMMCI is an expert resource in educating and training internal and external stakeholders about Evofem products. He/she will ensure our commitment to quality, compliance and corporate values.
Job Responsibilities:

  • Respond effectively to unsolicited medical information requests from external customers. Research and write accurate, evidence-based, balanced medical information SRLs and FAQs for Medical Affairs that results in effective communication with our internal and external stakeholders. Establish and conduct periodic review of current literature for evaluation and inclusion in responses that results in appropriate utilization of our therapies.
  • In collaboration with the external call center, evaluate and triage adverse drug events and product complaints, documenting accordingly. Refer escalations and consult requests to the appropriate internal stakeholders, as needed. Conduct monthly QA review of incoming medical inquiries to ensure adherence to corporate compliance.
  • Leads Medical review of US promotional resources through promotional review committee to certify that materials are medically and scientifically accurate, clinically relevant and balanced, as well as compliant with FDA regulations.
  • Works across various functions to maintain collaborative relationships, including Medical Science Liaisons, Regulatory, Clinical, Legal and Commercial partners to ensure they demonstrate scientific excellence.
  • Attends appropriate medical conferences to learn and evaluate new scientific, product or competitive information, and support the Medical Information booth.
    Competencies:
    • Strong working knowledge of FDA regulations regarding drug promotion and the dissemination of medical and product information.
    • Excellent verbal and written communication skills with experience in medical writing required.
    • Proven ability to perform in-depth biomedical publication searching, analysis and interpretation of data.
      Supervisory Responsibility:
      • No supervisory responsibilities.
        Education and Qualifications:
        • Advanced degree in a healthcare discipline or basic science (PharmD, RPh, PhD, MSN, etc.) preferred.
        • Minimum of 5 year' experience in the pharmaceutical industry with drug or medical information experience (fellowship or residency in the pharmaceutical industry will apply).
        • Women's health experience preferred.
        • Knowledge of pharmacotherapy.
          Travel:
          • 5-10% overnight travel may be required
            Evofem Biosciences provides a competitive salary and generous benefits package including medical, dental, vision coverage, 401k, paid vacation and Holidays.
            Evofem Biosciences is an Equal Opportunity Employer
            *No agencies please*

Keywords: Evofem Biosciences, El Centro , Senior Manager, Medical Communications/Medical Information, Executive , San Diego, California

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