To assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country(ies) and ensure compliance with local and international clinical trials regulations and guidelines.
Essential functions of the job include but are not limited to:
- Keep an updated knowledge of the local clinical trial laws, regulations and guidelines to perform the assigned regulatory
- Preparation of Clinical Trial Application Forms (Country EudraCT form for EEA countries and/or National Application Form).
- Preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorisations/approvals for the conduct of the Clinical
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Providing CA/EC related information as
- Providing regular updates about CA and EC submissions to Vice President Regulatory/Designee, to the responsible person coordinating the submissions, to Clinical Project Manager and to the responsible Lead
- Participating in regulatory activities within the company and ensuring regulatory (CA and EC) related activities are performed according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Regular attendance to Regulatory
- Assisting training of CRAs (if applicable) to ensure they have the necessary knowledge for preparation of the clinical documents required for the regulatory submissions.
- Assuming other regulatory responsibilities if required and upon the request of Director, Regulatory/ VP, Regulatory.
- Medical/science background and /or relevant experience
- Prior clinical research and regulatory submissions experience
- Fluent in Spanish and English
- Computer literacy
- Good communication skills
- Good interpersonal skills
Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for n ovel therapeutics in various indications.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected] .
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