Offer summary

Qualifications:

A minimum of a Bachelor's degree in Life Sciences or Law is required., Experience with regulatory documentation and submissions to Ethics Committees and Regulatory Agencies is preferred., Knowledge of local regulatory guidelines and excellent organizational skills are essential., Fluency in Thai and English, with strong communication skills, is necessary. .

Key responsibilities:

Prepare and file clinical trial applications to regulatory authorities and Ethics committees in Thailand.

Draft, review, and negotiate agreements and legal documents for clinical studies.

Maintain the Clinical Trial Management System and ensure timely filing of essential documents.

Coordinate with internal departments to align site startup activities with contractual processes.

Job description

As a Regulatory Submissions Coordinator & Contract Specialist (Dual role), you will have the opportunity to work within Regulatory Submissions and contract negotiations, supporting our many projects and gaining some vital experience. You will be a productive member of the team, home-based in Thailand, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators and Contract Specialists, you will gain valuable hands on experience to enable you to develop a career in clinical research.

Responsibilities

Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Thailand (experience in other Asia Pacific countries would be a plus)
Prepare and submit responses to queries and amendments to clinical trial applications;
Ensure submissions comply with applicable regulations and guidance documents;
Advise team members on changing regulations and compliance requirements;
Maintain the Clinical Trial Management System and ensure timely filing of documents;
Collection of essential documents and preparation essential documents packages for drug release.
Drafting, reviewing, negotiating, and finalizing agreements, termination letters or other legal documents required for a clinical study;
Identify and assesses legal, financial, and operational risks and escalate to appropriate Contract Lead or Contract Manager;
Provide recommendations and alternative resolutions throughout negotiations using established escalation channels;
Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual process and mutually agreed up timelines;

Qualifications

A minimum of a Bachelor's degree is required (preferably in a Life Sciences field or Law);
Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
No previous industry experience mandatory for junior position level;
Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site for senior level;
Knowledge of local regulatory guidelines and legislation;
Excellent organizational and prioritization skills;
Use to work independently with a proactive approach;
Knowledge of Microsoft Office;
Fluency in Thai and English, additionally language is a plus; great attention to details and excellent oral and written communication skills.

Note: We kindly request to submit your resume and application in English langauge.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

Flexible work environment
Competitive compensation and benefits package
Competitive PTO packages
Structured career paths with opportunities for professional growth
Company-sponsored employee appreciation events
Employee health and wellness initiatives

Awards

Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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