Job Overview
Location
Remote, China
Job Type
Full-time
Category
HR & Recruiting
Date Posted
April 14, 2026
Full Job Description
đź“‹ Description
- • The Regulatory and Site Start Up Specialist ensures timely and high-quality clinical trial site activation in China by managing regulatory submissions, ethics committee interactions, and essential documentation in compliance with local and international regulations.
- • Day-to-day responsibilities include preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, reviewing and adapting Informed Consent Forms, managing essential document collection, supporting site contract negotiations, and acting as a Subject Matter Expert for site start-up activities.
- • Precision Medicine Group integrates clinical trial execution with scientific expertise, laboratory capabilities, and data sciences to accelerate therapy development, with a strong focus on Oncology and Rare Disease.
- • The role offers opportunities to deepen regulatory knowledge in China’s clinical trial landscape, contribute to process improvements, mentor team members, and gain cross-functional experience across Clinical Operations, Project Management, and Site Contracts.
🎯 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 experience as a Regulatory or Site Start-up Specialist in a CRO, pharmaceutical, or biotech environment.
- • Fluency in English and Mandarin (required for China-based role).
- • Strong communication, organizational skills, and proficiency in computerized information systems, spreadsheets, word processing, and email.
- • Preferred: Experience with milestone tracking systems, ability to prioritize workloads to meet deadlines, and advanced degree (MD, PhD, PharmD) or RAC certification/Masters in Regulatory Science.
🏖️ Benefits
- • Opportunity to work with a specialized CRO focused on Oncology and Rare Disease therapies.
- • Exposure to end-to-end clinical trial start-up processes in a growing global organization.
- • Potential to contribute to development of country-specific tools and guidance documents.
- • Support for professional growth through training, mentoring, and process improvement initiatives.
- • Equal Opportunity Employer commitment with accommodations available for individuals with disabilities.
Skills & Technologies
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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