Country Activation and Submission Representative
IQVIA Biotech
📍 Poland | Home-Based
About IQVIA Biotech
At IQVIA Biotech, we partner with innovative biotech companies to help transform scientific discoveries into life-changing therapies. Through dedicated teams, therapeutic expertise, and a biotech-focused delivery model, we support clinical development from early-phase studies through global registration programs.
We are currently seeking a Country Activation and Submission Representative to join our Site Activation team in Poland.
Role Overview
As a Country Activation and Submission Representative , you will be responsible for managing country-level regulatory and site activation activities across clinical studies in Poland. You will support studies from initial submission through study maintenance and close-out activities, working closely with investigative sites, project teams, and regulatory authorities.
This role requires strong knowledge of the Polish regulatory environment, EU Clinical Trial Regulation (EU CTR) submissions, and site activation processes.
Key Responsibilities
- Manage EU CTR submissions in Poland, including both initial submissions and amendments.
- Coordinate and oversee regulatory and site activation activities from study start-up through study maintenance and study end.
- Prepare, review, compile, and maintain Essential Document Packages (EDP).
- Manage country-specific Informed Consent Form (ICF) adaptations and related documentation.
- Act as the primary contact for investigative sites throughout the study lifecycle.
- Build and maintain strong relationships with sites through proactive communication and support.
- Prepare and submit regulatory documentation in accordance with local requirements and project timelines.
- Review, track, and follow up on approvals from regulatory authorities and ethics committees.
- Respond to and coordinate Requests for Information (RFIs) from Regulatory Authorities.
- Ensure all regulatory and site documents meet quality standards and compliance requirements.
- Support Site Activation Managers and project teams by providing local regulatory expertise and timeline guidance.
- Manage studies in both start-up and maintenance phases simultaneously, ensuring deliverables are completed on time.
- Participate in feasibility activities and support site identification processes.
- Contribute to site contract negotiations and feasibility assessments (preferred but not mandatory).
Required Qualifications
- Bachelor's Degree in Life Sciences or a related field.
- Experience within clinical research, with a focus on study start-up, regulatory affairs, or site activation activities.
- Hands-on experience with EU CTR submissions in Poland.
- Experience preparing and managing Essential Document Packages (EDPs).
- Understanding of Polish regulatory and ethics submission requirements.
- Experience handling initial submissions and amendments.
- Experience communicating directly with investigative sites and coordinating site activation activities.
- Ability to manage multiple studies and priorities simultaneously.
- Strong organizational and project management skills.
- Solid understanding of ICH-GCP guidelines and clinical trial regulations.
- Excellent verbal and written communication skills.
- Fluency in Polish and English.
Preferred Qualifications
- Experience responding to Regulatory Authority RFIs.
- Experience supporting study maintenance activities in addition to start-up.
- Exposure to site feasibility activities.
- Contract negotiation experience.
- Experience working within a CRO, biotechnology, or pharmaceutical environment.
What You'll Bring
- Strong attention to detail and quality-focused mindset.
- Ability to work independently in a remote environment.
- Effective stakeholder management skills.
- Strong problem-solving and organizational abilities.
- Capability to build collaborative relationships with sites, sponsors, and internal teams.
Why IQVIA Biotech?
- Opportunity to work with innovative biotech sponsors developing next-generation therapies.
- Home-based flexibility in Poland.
- Exposure to global and regional clinical development programs.
- Collaborative, supportive, and growth-focused environment.
- Career development opportunities within a world-leading clinical research organization.
Join IQVIA Biotech and help accelerate the delivery of innovative treatments to patients worldwide.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is 151.200,00 zł - 280.700,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
