Manager Research Regulatory Affairs

Mckesson Corporation; North Carolina; Hybrid; USD 125,000 - 180,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials across the U.S. SCRI is a subsidiary of McKesson, focused on advancing cancer therapies and improving patient outcomes.

The Manager of Research Regulatory Affairs will oversee all regulatory operations for SCRI, manage the Regulatory Department, and develop short- and long-term regulatory strategies for Clinical Operations.

Qualifications

• Knowledge of FDA and GCP guidelines.
• Knowledge of organizational policies, procedures, and systems.
• At least three years of experience in regulatory affairs.
• At least one year of experience in a supervisory role.

Responsibilities

• Oversee all aspects of regulatory operations for SCRI and manage the Regulatory Department.
• Develop and implement short- and long-term strategies for regulatory compliance for Clinical Operations.
• Ensure FDA regulatory compliance and oversee regulatory audits.
• Coordinate with department directors, primary investigators, sponsors, and external entities.
• Manage, plan and schedule activities for the regulatory department.
• Establish and enforce procedures to ensure trial teams/sites comply with laws, SOPs and guidelines.
• Develop and implement regulatory policies for sites and Clinical Operations.
• Manage regulatory affairs across multiple clinical trials per FDA and GCP guidelines.
• Maintain relationships with FDA and industry partners regarding regulatory compliance.
• Resolve key regulatory issues with industry partners and government agencies.
• Develop an archiving system for study regulatory documentation.
• Advise management on regulatory issues and provide guidance as needed.
• Attend network meetings, training and mentor staff as needed.
• Drive improvements, tools and forms to enhance efficiency and quality.

Education

Bachelor's Degree

Job description

It's More Than a Career, It's a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

As the Manager of Research Regulatory Affairs you will oversee all aspects of the regulatory operations for Sarah Cannon Research Institute (SCRI) 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 SCRI 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

About Sarah Cannon Research Institute

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.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.