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Precision For Medicine is a healthcare and life sciences services organization that helps pharmaceutical and biotechnology companies develop and commercialize therapies, with expertise spanning oncology, rare diseases, and autoimmune conditions. Its work combines clinical trial management, laboratory services, biospecimen collection, biomarker capabilities, and manufacturing support to coordinate complex development programs. By connecting these services across the clinical research process, Precision For Medicine helps teams address operational challenges and advance potential treatments toward patients.
Regulatory and Site Start-Up Specialist - South Korea (Remote)
Support clinical trial submissions, site activation, and essential document management in South Korea. Precision for Medicine combines clinical operations, scientific expertise, laboratory services, and data sciences.
Description
- Ensure timely, high-quality site activation readiness across assigned countries and sites while identifying and mitigating risks.
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies.
- Communicate with Competent Authorities and Ethics Committees and manage their responses.
- Provide regular submission updates to Start-Up or Regulatory Leads, Project Managers, and project teams.
- Maintain project plans, trackers, and regulatory intelligence systems.
- Help develop study-specific start-up plans, IMP release requirements, and essential document review criteria.
- Coordinate with site CRAs to align communications and secure site collaboration.
- Prepare, review, and manage essential documents for site activation and IMP release.
- Adapt country- and site-specific Patient Information Sheets and Informed Consent Forms.
- Coordinate document translations and facilitate translations required for submissions.
- Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.
- Serve as the subject matter expert for site activation critical-path data, including regulatory timelines, contracts, budgets, and required reviews.
- Support study budget negotiations and investigator contract execution when needed.
- Assist with feasibility activities and site outreach as required.
- Maintain knowledge of local clinical trial laws and regulations and share relevant updates within Precision for Medicine.
- Maintain audit and inspection readiness and file documents according to TMF and study-specific plans.
- Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring.
- Perform additional duties assigned by management.
Requirements
- Bachelor’s degree in life sciences or a related field, preferably in a scientific or healthcare discipline; Registered Nurse (RN) qualification or an equivalent combination of education, training, and experience is also acceptable.
- At least one year of experience as a Regulatory or Site Start-Up Specialist, or in a comparable CRO or pharmaceutical/biotechnology role, or equivalent relevant experience and demonstrated competencies.
- Strong communication and organizational abilities.
- Experience with computerized information systems, electronic spreadsheets, word-processing software, and email.
- Fluency in English and, for positions in non-English-speaking countries, the local language of the country where the role is based.
- Relevant regulatory and site start-up experience in the specific country is preferred.
- Experience with milestone tracking tools or systems is preferred.
- Ability to prioritize work and meet deadlines is preferred.
- An advanced degree in medical or life sciences, MD, PhD, PharmD, RAC certification, or a Master’s in Regulatory Science is preferred.
Benefits
- Regular full-time employment.
- Remote work arrangement.
- Equal opportunity employment.
- Reasonable accommodation is available for applicants with disabilities.
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