Study Start Up Submissions Coordinator

2+ years

Not Disclosed

Singapore

10 Jan. 13, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Submissions Coordinator

Location: Singapore
Department: Clinical Operations
Company: Medpace

Job Summary

Medpace is seeking a full-time Regulatory Submissions Coordinator to join our Singapore office. In this critical role, you will support and drive the activation of investigative sites for clinical trials across all phases. This position offers a dynamic career path with opportunities for professional growth, recognition, and international exposure.

If you’re ready to apply your expertise in regulatory submissions, problem-solving, and project management while advancing your career, this is the perfect opportunity.

Responsibilities

Coordinate activities to activate investigative sites for clinical trials across all phases.
Prepare, review, and submit applications to regulatory agencies and ethics committees.
Communicate with global study teams and track site activation progress.
Identify potential risks to site activations and develop mitigation strategies.
Provide expert guidance on ethics and regulatory submissions.
Review and finalize essential documents required for site activation.
Act as the primary contact for ethics and regulatory submission-related activities.
Maintain compliance with applicable regulations and guidance documents.
Advise sponsors on regulatory requirements and evolving regulations.
Ensure timely submission and filing of regulatory documents.

Qualifications

Education: Bachelor’s degree in a scientific field or an equivalent combination of education and experience.
Experience:
- At least 2 years of relevant experience at a CRO, pharmaceutical company, or investigative site as a study coordinator.
- Experience in preparing and submitting regulatory applications.
- Hands-on experience with regulatory documentation submissions and responses to queries.
Skills:
- Strong organizational and communication abilities.
- Proficiency in Microsoft® Office.
- In-depth knowledge of ICH-GCP and regulatory guidelines.
- Proactive attitude with a willingness to learn and adapt.

About Medpace

Medpace is a global clinical contract research organization (CRO) that provides Phase I-IV clinical development services. We are committed to advancing safe and effective medical therapeutics through science and precision. Headquartered in Cincinnati, Ohio, Medpace has a global presence with over 5,000 employees in 40+ countries.

Why Join Medpace?

People. Purpose. Passion.

Growth Opportunities: Structured career paths to advance professionally.
Positive Impact: Contribute to the development of life-saving medical therapies.
Supportive Environment: Work with an empowered team committed to excellence.

Medpace Perks

Workplace Flexibility: Supportive and adaptable work environment.
Benefits: Competitive compensation and PTO packages.
Professional Development: Training programs and international exposure.
Employee Engagement: Company-sponsored events and wellness initiatives.

Awards & Recognition

Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
Consistently awarded CRO Leadership Awards for expertise and reliability by Life Science Leader magazine.

What to Expect Next

Qualified candidates will be contacted by a Medpace team member to discuss next steps.

Medpace is an Equal Opportunity Employer, fostering diversity and inclusion.

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