Regulatory and Site Start-Up Specialist

🔥 15 hours ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 19%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Deliver timely and high-quality site activation readiness within assigned country/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 • Interact with Competent Authorities and Ethics Committees and handle responses • Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams • Maintain project plans, trackers, and regulatory intelligence tools • Support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRAs to align communication and secure site collaboration • Prepare, review, and manage essential documents required for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Facilitate document translations and coordinate translation activities • Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams • Act as subject matter expert for site-level critical path and Site Activation data points • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach when needed • Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine • Maintain audit/inspection readiness and file documents according to TMF or study-specific plans • Support Pre-Study Site Visits when needed • Support process improvement initiatives, training, and mentoring • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience • 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies • Strong communication and organizational skills are essential • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required • Fluency in English and for non-English speaking countries the local language of country where position based • Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country preferred • Experience using milestone tracking tools/systems preferred • Ability to prioritize workload to meet deadlines preferred • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science preferred

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • AI-generated insights during the application journey, including resume review and interviews, with opt-out option