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Regulatory and Site Start Up Specialist

2 hours, 41 minutes ago
Taiwan
Full-time
Junior
Compliance Manager
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 102

Description

  • Deliver site activation readiness on time and with high quality for assigned countries and sites, while identifying and mitigating risks.
  • Prepare Clinical Trial Application Forms and submission dossiers, including initial submissions, amendments, and notifications, for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage communications with Competent Authorities and Ethics Committees, including handling responses and providing submission status updates to study leadership and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities.
  • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site review and collection of essential documents for site activation and IMP release.
  • Customize country- or site-specific Patient Information Sheets and Informed Consent Forms and coordinate document translations.
  • Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on study status and deliverables.
  • Act as a subject matter expert for site activation data points, including authority timelines, ethics timelines, and site contract and budget negotiation requirements.
  • Support negotiation of study budgets and execution of investigator contracts when required.
  • Maintain audit and inspection readiness and file documents according to TMF plans and study-specific requirements.
  • Support feasibility outreach and pre-study site visits when needed.

Requirements

  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent education, training, and experience.
  • A pharmacy qualification or work experience as a pharmacist is highly beneficial.
  • At least 1 year of experience as a Regulatory or Start-Up Specialist, or in a comparable role, within a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing software, and email.
  • Fluency in English.
  • Relevant regulatory and site start-up experience, 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.

Benefits

  • Opportunity to work on groundbreaking cancer therapies and other precision medicine research.
  • A workplace culture where employee contributions are appreciated and ideas are valued.
  • Chance to have input that can influence positive change within the company.
  • Equal opportunity employment protections.
  • Reasonable accommodation support for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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