Manager Research Regulatory Affairs

McKesson’s Corporate; United States; On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Manager of Research Regulatory Affairs to oversee regulatory operations for SCRI across clinical trials.

Responsibilities include developing strategies for regulatory compliance with FDA and GCP, managing the Regulatory Department, and coordinating audits with sponsors and government agencies. Bachelor's degree required; 3+ years in regulatory affairs; 1+ year supervisory experience. On-site role with a total rewards package.

Qualifications

• Bachelor’s Degree required.
• Knowledge of FDA and GCP guidelines.
• Experience in regulatory affairs and supervision.

Responsibilities

• Oversee all regulatory operations for SCRI and manage the Regulatory Department.
• Develop and implement regulatory policies and procedures for Clinical Operations.
• Manage regulatory affairs between the organization and FDA; coordinate audits.
• Provide training, mentoring and ensure compliance with laws, SOPs, and guidelines.
• Develop strategies for regulatory compliance for industry sponsors and sites.

Skills

Regulatory affairs knowledge

FDA regulations

GCP guidelines

Leadership

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 MissionPeople 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 departmentYou 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 guidelinesYou 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 sitesYou 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 networksYou 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 auditorsYou will resolve key regulatory issues with Pharmaceutical Industry Partners and Government AgenciesYou will develop and implement an approved archiving system for study specific regulatory documentation and correspondenceYou will apprise management of important regulatory issues and obtains guidance when necessaryYou will attend network meetings, conference calls and monthly staff meetings as appropriateYou will visit strategic sites and provides training and mentoring as neededYou will provide proactive and creative recommendations on how to meet goals and handle identified deviationsYou will be responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs SpecialistsYou will be responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issuesYou will initiates improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projectsYou should have for this position:A Bachelor’s DegreeKnowledge of scientific and clinical research terminologyKnowledge of FDA and GCP guidelinesKnowledge of organizational policies, procedures, and systems.At least three years of experience in regulatory affairsAt least on year of experience in a supervisory roleAbout Sarah Cannon Research InstituteSarah 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.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.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 .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.