Regulatory and Site Start-Up Specialist

🔥 0 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 10%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver site activation readiness on time and to quality standards within assigned country/sites, while foreseeing and mitigating risks • Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide updates on submissions to Start Up/Regulatory Leads and the Project Manager/Project Team • Maintain project plans, project trackers, and regulatory intelligence tools • Prepare or support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRA to align communication and secure site review • Review and manage collection of essential documents for site activation/IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Facilitate document translations and coordinate translation activities • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables • Act as subject matter expert for site-level critical-path data points, including authority and ethics committee timelines, site contracts, budget negotiations, and required reviews • Support study budget negotiations and investigator contract execution when required • Support feasibility outreach to assess investigator interest in potential studies • Maintain current knowledge of local clinical trial laws and regulations and share knowledge within PFM • Maintain audit/inspection readiness and file documents according to TMF or study-specific plans • Support clinical teams performing Pre-Study Site Visits

🎯 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 • A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial • 1 year or more as a Regulatory or Site Start-Up specialist (or comparable role) in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required • Fluency in English • Relevant regulatory and site start-up experience preferred • Experience using milestone tracking tools/systems preferred • Ability to prioritize workload to meet deadlines preferred • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

• Employees feel appreciated for their contributions • Input and ideas valued and nurtured, impacting positive change for the company • Equal Opportunity Employer • Reasonable accommodation available during the application process