What are the responsibilities and job description for the Director, Global Regulatory Affairs Study Start Up (level dependent on experience) position at CTI?
Job Purpose/ Summary: Responsible for overall global strategies and operational aspects of Regulatory Affairs Study Start-up (RASSU) department at CTI. Provides leadership and direction to all members of global RASSU, ensuring timelines, budget, and quality measures are met. Creates and fosters a collaborative work environment, attracting / mentoring high-performing team members. This position is open to candidates globally.
What You'll Do:
- Manages and oversees global RASSU activities.
- Provides guidance to RASSU regional leaders and fosters their collaboration and growth.
- Ensures clinical study timelines, budgets, and quality measures are met and meet / exceed accepted corporate standards.
- Embraces and implements programs that ensure quality and efficient RASSU activities.
- Attracts, develops, coaches, and retains high-performance team members, empowering them to elevate their levels of responsibility, span of control, and performance.
- Prepares and manages departmental budgets and implements cost-effective measures.
- Ensures Global Standard Operating Procedures (GSOPs) are reviewed and updated in a timely manner and abide by local guidelines and regulations.
- Oversees and administers training of all RASSU staff.
- Ensure appropriate staff review of GSOPs.
- Ensures Quality Assurance (QA) suggestions and findings are addressed in a timely manner.
- Represents CTI in developing new business, assisting with Clinical Operations presentations, reviewing bid proposals, and reviewing and facilitating out-of-scope (OOS) activities.
- Embraces departmental collaboration and harmonization on a global platform to streamline study start up and ensure continual process improvement, increase efficiencies and advances technology/software utilization.
- Drives organizational change and process harmonization within the global RASSU organization.
- Manages departmental financial metrics to meet corporate objectives
What You'll Bring:
- At least 15 years of CRO or relevant experience, including previous experience, managing large global teams and multinational complex aspects of global Regulatory Affairs and study start up activities
- MS or PhD degree in health-related area or equivalent experience as determined by CTI Management and Human Resources
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
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
