Start-up specialist/ Clinical research site activation

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 Lithuania, 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.

• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Lithuania (experience in Latvia and Estonia 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.

• 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 Lithuanian and English, additionally Latvian is a plus; and
• Great attention to detail and excellent oral and written communication skills.

We kindly ask to submit applications in English.

We would appreciate if you could indicate the status of your work permit.