As the
Manager of Regulatory Affairs you will oversee all aspects of the regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department. You will be responsible for developing and implementing short and long term strategies for the regulatory compliance for the site Clinical Operations. You will ensure Sarah Cannon adheres to and maintains Food and Drug Administration (FDA) regulatory compliance as well as oversees any regulatory audit. You will work closely with the department directors and/or primary investigators, industry sponsors and other outsides entities.
- You will manage, directs, plan and schedule activities and programs for the regulatory department
- You will establish and enforce procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, standard operating procedures (SOPs), and other applicable guidelines
- You will develop and implement regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sites
- You will manage the regulatory affairs between the organization for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines; for individual sites, studies, sponsors and/or other networks
- You will manage the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors
- You will resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies
- You will develop and implement an approved archiving system for study specific regulatory documentation and correspondence
- You will apprise management of important regulatory issues and obtains guidance when necessary
- You will attend network meetings, conference calls and monthly staff meetings as appropriate
- You will visit strategic sites and provides training and mentoring as needed
- You will provide proactive and creative recommendations on how to meet goals and handle identified deviations
- You will be responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists
- You will be responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issues
- You will initiates improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects
You should have for this position:
- A Bachelor's Degree
- Knowledge of scientific and clinical research terminology
- Knowledge of FDA and GCP guidelines
- Knowledge of organizational policies, procedures, and systems.
- At least three years of experience in regulatory affairs
- At least on year of experience in a supervisory role
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: careers.mckesson.com.
