Regulatory and Site Start Up Specialist

🔥 9 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 20%

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 and foresee and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees and other local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up/Regulatory Leads and the Project Manager/Project Team • Maintain project plans, trackers and regulatory intelligence tools • Prepare or support study-specific start-up plans, IMP release requirements and essential document review criteria • Partner with the assigned site CRA on communication and site readiness • 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 • Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts teams • Maintain site activation critical-path data, including authority and ethics timelines, contracts and budget negotiations • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach • Maintain knowledge of local clinical-trial laws and regulations and distribute regulatory knowledge within the organization • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans • Support Pre-Study Site Visits when required

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • Qualification in Pharmacy/work experience as a Pharmacist 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 • 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 • Reasonable accommodation available during the application process for individuals with disabilities