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

Health Care

251-1K (427)

Founded 2012

164 open positions

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Regulatory and Site Start Up Specialist

1 hour, 41 minutes ago

Taiwan

Full-time

Junior

Operations Specialist

Project and Program Management

Apply Now

Precision Medicine Group

Pharmaceuticals

251-1K

Founded 2012

View All Jobs 164

Description

Ensure timely, high-quality site activation readiness 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 interactions with Competent Authorities and Ethics Committees, including handling questions and responses related to study submissions.
Provide regular status updates on CA and EC submissions to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
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 the site CRA to align communication and secure site review and essential document collection for site activation and IMP release.
Customize country- and 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 startup status and deliverables.
Act as a subject matter expert for critical path site activation data, including timelines, contract and budget negotiation requirements, and other review milestones.
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 pre-study site visits when needed.

Requirements

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

Benefits

Opportunity to work for a growing organization focused on ground-breaking cancer therapies.
Employees’ contributions are recognized and appreciated.
Input and ideas are valued and encouraged, with opportunities to help drive positive change.
Equal Opportunity Employer commitment.
Reasonable accommodation support for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

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