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    Vice President, Regulatory Strategy

    Medpace Clinical Research India Pvt. Ltd.
    5+ years
    Preffered by Company
    Remote, USA
    10 Aug. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Head of Regulatory Strategy

    Location: Cincinnati, OH

    Company Overview:

    Medpace is a leading full-service Contract Research Organization (CRO) dedicated to providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With our headquarters in Cincinnati, Ohio, and a global presence spanning over 40 countries, we are committed to accelerating the development of safe and effective medical therapeutics. Our expertise covers a wide range of therapeutic areas, including oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, and anti-viral and anti-infective treatments.

    Role Summary:

    We are seeking a full-time Head of Regulatory Strategy to join our Cincinnati team. This strategic leadership position is crucial for guiding our interactions with the FDA and developing regulatory strategies designed to expedite approval processes. The ideal candidate will possess a deep understanding of North American (US FDA) regulatory science, drug/biologic development, and therapeutic areas, enabling them to effectively influence cross-functional discussions with Sponsors and key stakeholders.

    Responsibilities:

    • Regulatory Expertise: Provide expert guidance on regulatory strategy to meet industry standards by applying extensive knowledge of regulatory requirements, guidelines, procedures, and agency precedents.
    • Strategic Advising: Advise project teams on the development and implementation of regulatory strategies throughout the clinical development lifecycle.
    • Collaboration: Work closely with regulatory and development teams on strategic projects, including gap analyses, meetings with regulatory authorities, protocol development, and other key deliverables.
    • Regulatory Knowledge: Maintain advanced knowledge of evolving regulatory requirements and advise teams accordingly.
    • Agency Interaction: Engage with national and regional regulatory agencies, including the US FDA.
    • Proactive Solutions: Review relevant regulations and guidance to develop proactive solutions for regulatory challenges.
    • Team Leadership: Lead a team of physicians and regulatory staff with strategic expertise.
    • Cross-Functional Support: Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics teams.

    Qualifications:

    • Education: MD, PhD in Life Sciences, or another advanced degree.
    • Experience: Minimum of 5 years of experience in regulatory drug development, with expert knowledge in one or more therapeutic areas. Professional experience at the FDA, such as a Clinical Team Leader, is preferred.
    • FDA Experience: Extensive experience working and partnering with the FDA is required.

    Why Medpace?

    At Medpace, we value People, Purpose, and Passion. Join us to make a significant impact on patients' lives and advance your career in a dynamic environment.

    Cincinnati Perks:

    • Work Flexibility: Hybrid work-from-home options available, depending on the position and level.
    • Generous PTO: Competitive paid time off packages starting at 20+ days.
    • Compensation: Attractive salary and benefits package.
    • Work-Life Balance: Flexible work schedules, company-sponsored appreciation events, and wellness initiatives.
    • Community Engagement: Opportunities for involvement with local nonprofit organizations, and discounts on local sports games, fitness gyms, and attractions.
    • Campus Amenities: Modern, eco-friendly campus with an on-site fitness center.
    • Career Development: Structured career paths with professional growth opportunities and discounted tuition for UC online programs.

    Awards and Recognition:

    • Top Workplace: Named a Top Workplace in 2024 by The Cincinnati Enquirer.
    • Forbes Recognition: Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
    • CRO Leadership Awards: Continually honored with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

    Apply Today:

    If you are a strategic leader with extensive experience in regulatory science and a passion for advancing drug development, we invite you to apply and join our innovative team at Medpace.

    Make a Difference Tomorrow. Join Us Today.

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