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    Regulatory & Start Up Specialist, Cfsp

    Iqvia
    3+ years
    Not Disclosed
    Mexico
    11 Nov. 23, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Description: Regulatory & Start-Up Specialist

    Location

    Home-Based (Argentina & México)

    Role Overview

    Join our cFSP team as a Regulatory & Start-Up Specialist to perform country-level site activation (SA) tasks in compliance with local and international regulations, SOPs, project requirements, and contractual/budgetary guidelines.

    Key Responsibilities

    1. Site Activation Tasks

      • Serve as the Single Point of Contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other departments.
      • Conduct start-up and site activation activities as per applicable regulations, SOPs, and work instructions.
      • Prepare and review site regulatory documents for completeness and accuracy.
      • Oversee document distribution to sites and internal project teams.

    2. Regulatory Compliance and Tracking

      • Ensure adherence to SOPs, Work Instructions (WIs), and quality standards for deliverables and project timelines.
      • Maintain and update internal systems, databases, and tracking tools with project-specific details.
      • Review, track, and manage the progress, approval, and execution of key documents, including regulatory approvals, ethics submissions, Informed Consent Forms (ICFs), and Investigator Pack (IP) releases.

    3. Local Expertise

      • Provide local regulatory expertise to SAMs and project teams during both initial and ongoing project timeline planning.
      • Support submissions to regulatory authorities (e.g., COFEPRIS, ANMAT) and ethics committees.

    4. Quality Assurance

      • Conduct quality control reviews of documents provided by sites.
      • Ensure alignment with GCP/ICH guidelines and applicable regulatory standards.

    5. Stakeholder Interaction

      • Act as a liaison for sponsors on specific project initiatives, ensuring seamless communication and deliverables.

    Qualifications & Skills

    • Education:
      Health Sciences degree or related field.

    • Experience:

      • Minimum of 3 years of clinical research experience in the regulatory domain.
      • Proven expertise in local regulatory submissions, ethics committee presentations, and familiarity with COFEPRIS/ANMAT requirements.

    • Technical Knowledge:

      • Comprehensive knowledge of GCP/ICH and applicable regulatory guidelines.
      • Proficiency in handling Informed Consent Forms (ICFs) and regulatory document submissions.

    • Language:

      • Advanced proficiency in English.

    • Skills:

      • Strong organizational and time management abilities.
      • Effective communication and interpersonal skills.

    Why Join Us?

    Be a part of a dynamic and collaborative environment, contributing to impactful clinical research projects that comply with global standards. Apply your expertise in regulatory processes while working with a global team to advance healthcare innovation.

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