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Regulatory and Site Start Up Specialist

2 hours, 53 minutes ago
South Korea
Full-time
Junior
Compliance Manager
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 102

Description

  • Ensure timely, high-quality site activation readiness for assigned countries and sites while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers, including initial submissions, amendments, and notifications, for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage interactions with Competent Authorities and Ethics Committees, including responding to questions and requests for study purposes.
  • Provide regular status updates on CA and EC submissions to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure review and collection of essential documents needed for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms, including coordinating translations.
  • Coordinate with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
  • Serve as a subject matter expert on site activation critical path data points, including authority timelines, ethics reviews, and contract/budget negotiation requirements.
  • Support negotiation of study budgets and execution of investigator contracts when required.
  • Support feasibility efforts by assisting with site outreach to assess investigator interest in potential studies.
  • Maintain knowledge of local clinical trial laws and regulations and help distribute that knowledge within the organization.
  • Maintain audit and inspection readiness and file documents in the TMF according to the TMF plan and study-specific requirements.
  • Support clinical teams during pre-study site visits when required.

Requirements

  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • At least 1 year of experience as a Regulatory or Start Up Specialist, or a comparable role, in a CRO or pharmaceutical/biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing software, and email.
  • Fluency in English.
  • Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload and meet deadlines is preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Opportunity to work in a growing organization serving clients developing groundbreaking cancer therapies.
  • Employee contributions are appreciated, with input and ideas valued and nurtured.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy protections for application data, including a separate CA privacy notice for California applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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