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Regulatory and Site Start Up Specialist

Precision Medicine Group

Job Overview

Location

Remote, Taiwan

Job Type

Full-time

Full Job Description

📋 Description

• Regulatory and Site Start Up Specialist responsible for ensuring timely and high-quality site activation readiness within assigned countries/sites, including risk mitigation and regulatory compliance.
• Day-to-day duties include preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees, managing communications with regulatory bodies, maintaining project plans and trackers, customizing informed consent documents, coordinating translations, and supporting site activation processes.
• Precision Medicine Group is a Clinical Research Organization specializing in precision medicine, with expertise in rare diseases, oncology, and integrated clinical trial solutions combining medical, operational, and data analytics capabilities.
• The role offers opportunities to develop deep regulatory expertise, gain hands-on experience in global site start-up processes, contribute to life-saving cancer therapy research, and grow within a mission-driven organization that values employee input and innovation.

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 1 year or more as a Regulatory or Site Start-up specialist in a CRO, pharmaceutical, or biotech industry
• Fluency in English
• Strong communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing, and email

🏖️ Benefits

• Opportunity to work on groundbreaking cancer therapies and rare disease research
• Employee ideas are valued and nurtured, with input impacting positive company change
• Equal Opportunity Employer committed to diversity and inclusion
• Support for reasonable accommodations during the application process
• Clear communication about legitimate hiring practices to prevent fraud

Skills & Technologies

GCP

Remote

Degree Required

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Precision Medicine Group

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About Precision Medicine Group

Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.

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