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Precision Medicine Group
Precision Medicine Group
1,001 – 5,000 Employees
H1B Visa SponsorConsultingHealthcareLogistics
Precision Medicine Group helps pharmaceutical and life sciences organizations develop and commercialize products by bringing together expertise in precision medicine, laboratory science, translational informatics, regulatory affairs, payer insights, and marketing communications. Its work spans biomarker-driven research and development, clinical and commercial strategy, and support across the product lifecycle, from launch through maturity. The company operates through Precision for Medicine, which focuses on clinical solutions, and Precision AQ, which provides commercial solutions for life sciences clients.
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Regulatory and Site Start-Up Specialist — South Korea (Remote)

Support clinical trial submissions and site activation in South Korea for Precision for Medicine, a life sciences CRO. Manage essential documents, ethics approvals, contracts, and country-specific regulatory requirements.

KRSouth KoreaRemoteFull-timeJuniorEnglish RequiredCompliance

Description

  • Ensure timely, high-quality site activation readiness across assigned South Korean sites while identifying and reducing risks
  • Prepare Clinical Trial Application forms and submission dossiers for competent authorities, ethics committees, IRBs, and other relevant local bodies
  • Engage with competent authorities and ethics committees and manage their responses
  • Provide regular submission updates to regulatory and start-up leads, project managers, and project teams
  • Maintain project plans, tracking tools, and regulatory intelligence systems
  • Support study-specific start-up plans, IMP release requirements, and essential document review standards
  • Work with assigned site CRAs to align communications and secure site cooperation
  • Prepare, review, and manage essential documents for site activation and IMP release
  • Adapt country- and site-specific Patient Information Sheets and Informed Consent Forms
  • Arrange document translations and coordinate translation activities
  • Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
  • Serve as the subject matter expert for site-level critical-path activities and site activation data
  • Assist with study budget negotiations and investigator contract execution when needed
  • Support feasibility outreach to potential sites as required
  • Keep current with local clinical trial laws and regulations and share relevant knowledge within Precision for Medicine
  • Maintain audit and inspection readiness and file documents according to TMF or study-specific plans
  • Support Pre-Study Site Visits when required
  • Contribute to process improvement, training, and mentoring initiatives
  • Complete additional duties assigned by management

Requirements

  • Bachelor’s degree in life sciences or a related discipline, preferably scientific or healthcare-focused, or Registered Nurse qualification; equivalent education, training, and experience may be considered
  • At least one year of experience as a Regulatory or Site Start-Up specialist, or in a comparable CRO, pharmaceutical, or biotechnology role, with relevant experience or demonstrated competencies
  • Excellent communication and organizational abilities
  • Practical experience with computerized information systems, electronic spreadsheets, word processing, and email
  • Fluency in English and, where applicable, the local language of the country in which the role is based
  • Country-specific regulatory and site start-up experience, including feasibility, contract negotiation, and competent authority, ethics committee, or IRB submissions, preferred
  • Experience with milestone tracking tools or systems preferred
  • Ability to organize competing priorities and meet deadlines preferred
  • Advanced medical or life sciences degree such as MD, PhD, or PharmD, RAC certification, or a master’s degree in Regulatory Science preferred

Benefits

  • Equal Opportunity Employer
  • Reasonable accommodations are available for applicants with disabilities
  • AI-generated application support, including resume review and interviews, with an option to opt out

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