Ref #: 29213

Employment type: Permanent - Full-Time

Location: Poland

Posted: 19-May-2021


Prepare and submit Clinical Trial Authorisation (CTA) applications and substantial amendments to competent authorities throughout Europe

Key Responsibilities:
• Prepare, review and submit Clinical Trial Authorisation (CTA) applications and substantial amendments to competent authorities throughout Europe through the CTIS EU portal
• Managing the coordination of all central authority submissions to ensure timelines are met.
• Managing escalations, responding to governmental agencies and driving the submissions process.
• Coordinating the submission process of clinical trial applications and perform quality control on the central submissions
• Drives global submission management activities for their assigned assets.
• Liaises with Study Management teams, regarding essential core documents that cross both HA and EC submission and translation processes
• Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development

Required experience and qualifications:
• Preferably Master/Bachelor degree in life sciences
• Fluent English – written and spoken
• Strong Regulatory CTA submission experience
• Experience in preparing submissions for both Country Health Authority and Central Ethics Committees.
• Ability to work under pressure and achieve timely submission and regulatory approvals
• Good computer skill
• Strong attention to detail
• Ability to work independently in a structured and pro-active manner as well as part of the different trial teams
• Very good communication skills - ability to communicate and build relationships with various stakeholders

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.