Job Description

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

What You’ll Do

• Facilitate the development and management of regulatory aspects of multiple studies from the planning, operational and analysis phase to report writing and regulatory submission

• Interact with internal and external study team members to guide regulatory aspects of studies and projects to assure regulatory compliance and sponsor satisfaction

• Facilitate communication among Regulatory staff and study team members to assure realization of regulatory timeline milestones

• Oversee regulatory document processes and regulatory specific timeline assessments for each study; monitors against study progress and ensures study activity is in compliance with relevant processes; suggests and implements alternative solutions for regulatory issues identified and takes corrective action where necessary

• Assess regulatory resource needs and establishes appropriate teams for each study in conjunction with specific study goals; monitors ongoing resource needs against performance

• Ensure appropriate review tools are used in order to track and report progress/metrics; ensures timely tracking entry of study information throughout life of all studies for internal use, and reviews by study sponsor and external users as required

• Assess scope of regulatory work against client contractual agreements and assists in changes to scope orders

• Participate/lead regular meetings with study staff in order to facilitate satisfaction of timeline milestones and appropriate study maintenance

• Facilitate the development and management of regulatory aspects of multiple studies from the planning, operational and analysis phase to report writing and regulatory submission

• Report relevant study progress, issues, and scope of work considerations to head of Regulatory Affairs.

• Provide direct supervision, guidance, and mentoring to regulatory staff specifically and to all CTI staff generally, while encouraging independence and refining skills and experiences in all staff members

• Provide appropriate education and training to CTI staff to maintain up-to-date understanding of International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) and other regulatory guidelines

What You Bring

• Excellent verbal and written communication skills
• Excellent organizational, time and personnel management skills
• Excellent decision-making and creative problem-solving skills
• Excellent customer service and interpersonal skills
• Ability to develop, organize, and manage multiple tasks
• Ability to work independently
• Proficient in use of computer and software systems
• Ability to understand, interpret, and explain complex regulatory requirements and details
• Demonstrated knowledge and clear understanding of overall drug development processes including experience with all phases of clinical research processes
• Ability to manage direct reports with varying levels of experience
• A minimum of 10 years relevant pharmaceutical or CRO Clinical Regulatory experience
• Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP)/ International Council for Harmonisation (ICH) regulations and guidelines
• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy or health science or equivalent relevant experience

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process