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Regulatory and Site Start Up Specialist

5 hours, 35 minutes ago
Taiwan
Full-time
Junior
Project Coordinator
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 111

Description

  • Prepare clinical trial application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage responses and interactions with Competent Authorities and Ethics Committees for study purposes.
  • Provide regular updates on regulatory submissions and site start-up status to study leadership and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site activation.
  • Review and manage collection of essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country/site requirements.
  • Coordinate translations for study documents.
  • Track site activation critical-path items such as approvals, timelines, contracts, and budget negotiations.
  • Support study budget negotiations and investigator contract execution when required.
  • Assist feasibility teams with site outreach and investigator interest assessments.
  • Maintain knowledge of local clinical trial laws and regulations and share updates internally.
  • Ensure audit and inspection readiness and file documents in the TMF.
  • Support clinical teams during pre-study site visits when needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific/healthcare field, or RN, or equivalent education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • 1+ year of experience as a Regulatory or Start Up Specialist, or in a comparable role, within a CRO or pharmaceutical/biotech environment.
  • Strong communication and organizational skills.
  • Experience with computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant experience in regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions (preferred).
  • Experience using milestone tracking tools or systems (preferred).
  • Ability to prioritize workload to meet deadlines (preferred).
  • Advanced degree in medical or life sciences, MD, PhD, PharmD, RAC certification, or a Master’s in Regulatory Science (preferred).

Interested in this position?

Apply directly on the company website

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