Job Description
Overview
Our European activities are growing rapidly, and we are currently seeking a full-time, home-based Regulatory Submissions Coordinator & Contract Specialist (Dual role) to join our Clinical Operations team, in Latvia.
- 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. You will be a productive member of the team 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 Latvia;
- 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 assess 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 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;
- Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- 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 Latvian and English; and
- Great attention to detail and excellent oral and written communication skills.
We kindly ask to submit applications in English.
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