Life Sciences Regulatory Job at Medpace | Apply Now
A rare chance for professionals to step into a life sciences regulatory job at Medpace in Singapore. This role is essential for those seeking a clinical operations job where they can utilize their expertise and contribute to significant projects within the organization.
Job Details
- Position: Regulatory Submissions Coordinator
- Location: Singapore
- Reference Number: 12900
About Medpace
Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With a mission to accelerate the global development of safe and effective medical therapeutics, Medpace leverages local regulatory and therapeutic expertise across various areas, including oncology and cardiology. Headquartered in Cincinnati, Ohio, the organization employs more than 6,000 people across 40+ countries, making it a leader in the life sciences regulatory field.
Life Sciences Regulatory Job Description
The Regulatory Submissions Coordinator plays a critical role in the Clinical Operations team at Medpace. This position involves performing essential activities that lead to the activation of investigative sites in all phases of clinical trials. The successful candidate will prepare, review, and submit documents to regulatory agencies, ensuring compliance with applicable regulations. This life sciences regulatory job is perfect for individuals who are proactive and eager to learn within a dynamic environment.
Eligibility Criteria for Life Sciences Regulatory Job
- Bachelor’s degree in the life science field or equivalent combination of education and experience.
- Preferably 2 years of relevant working experience at a CRO, pharmaceutical company, or an investigative site as a study coordinator.
- Experience in preparing and submitting regulatory applications.
- Excellent organization and communication skills.
- Knowledge of Microsoft® Office.
- Knowledge of ICH – GCP guidelines.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to ethics committees and regulatory agencies.
- Proactive approach with the ability and willingness to learn and be challenged.
Life Sciences Regulatory Job – Key Responsibilities
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials.
- Prepare, review, and submit documents to regulatory agencies.
- Communicate with global study teams and personnel on study progress.
- Identify risks to site activations and mitigate them as necessary.
- Provide expertise and guidance to global study teams in ethics and regulatory submissions.
- Review and finalize essential documents required for site activation.
- Act as the main contact for ethical and regulatory submission-related activities.
- Ensure submissions comply with applicable regulations and guidance documents.
The life sciences regulatory job at Medpace represents an excellent opportunity for qualified candidates to make a significant impact in the clinical operations field. With a supportive work environment and a focus on professional growth, Medpace encourages individuals interested in a clinical operations job to apply at the earliest. This position not only promises career advancement but also the chance to contribute to meaningful projects within the life sciences sector. Explore Medpace careers today to find your place in this dynamic field.
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