at ICON Strategic Solutions in Springfield, Illinois, United States
Job Description
Develops and maintains quality monitoring plans for assigned programs. Executes and/or oversees the implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. Ensures agreed upon deliverables are completed within the timeframe established, including but not limited to review and assessment of Quality Risk Management reports; coordination of quality risk mitigation plans for identified issues; quality reviews of key clinical trial documents, and review and planning of submission activities as needed.
Supports Due Diligence activities, as requested, liaising with the applicable business and R&D Q&C L&A coordination personnel. Provides Good Clinical Practices (GCP) guidance to workgroups and to business partners. Ensure interpretation and consistency with compliance guidance provided. Assists in the facilitation of inspections by regulatory authorities for GCP, supporting R&D Q&C as appropriate.
What you will be doing:
+ Provides appropriate QM&C support to assigned cross-functional workgroups.
+ Responds independently to GCP-related compliance inquiries from other departments. Confers with quality professional staff when contacted for pro-active consultation to provide regulatory insight.
+ Manages inspection preparation activities and supports business during health authority inspections, in liaison with R&D Q&C as appropriate.
You are:
+ Advanced: minimum of 8 years of business experience
+ Ability to motivate professional colleagues and stakeholders
+ Conflict resolution/management and negotiation skills
+ Ability to independently plan, organize, coordinate, manage and execute assigned tasks
+ Experience of the key customers’ business processes and practices; experience of the overall drug development process is an asset
+ Knowledge of the overall drug development process;
+ Strong working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
+ Experience with regulatory submissions (NDA, BLA);
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
