Regulatory/Senior Regulatory Scientist
- Warszawa, mazowieckie
- Stała
- Pełny etat
- Read, write and speak fluent English; fluent in host country language
- Travel less than 5%
- Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Ensure regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles
- Advanced knowledge of ICON’s SOPs/WIs, ICH, GCP and appropriate regulations
- Advanced knowledge of ICON systems applicable to role
- Advanced knowledge of country/region Regulatory Agency (RA), Central Ethics Committee (CEC) and other country-level authority clinical trial requirements, as applicable
- Input to strategic planning of submissions to RA, CEC and other country-level bodies, including proactive identification and mitigation of risks, as applicable
- Direct interaction with RA, CEC and other country-level bodies
- Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation according to applicable requirements
- Arrange internal/external review of submission/documentation according to project requirements
- Track and file central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents entered
- Perform translation management according to project requirements
- Manage submissions through lifecycle to approval in line with contractual agreement
- Maintain agreed timelines
- Ensure project team is informed of applicable clinical trial Regulatory submissions and approvals in accordance with project requirements
- Collaborate with other roles in-country/region to meet ICON’s deliverables
- Ensure all project-specific training is completed on time, as applicable
- Adhere to study budget and proactively identifies out of scope activities
- Support the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence
- May mentor junior team members
- May contribute to the review of ICON systems and procedures as appropriate
- Any other duties deemed necessary to secure the success of ICON’s business