McKesson requires new employees to be fully vaccinated for COVID-19 as defined by the CDC, subject to applicable, verified accommodation requests.
McKesson Corporation is a Fortune 8 company and is one of the largest providers of healthcare supply chain management solutions, retail pharmacy, medical & pharmaceutical supplies, healthcare technology, community oncology and specialty care in the United States with revenues of $231 billion in 2020. The company was founded in 1833 by John McKesson and Charles Olcott in New York with a focus on importing and wholesaling pharmaceutical products. United by our ICARE shared principles, McKesson's 80,000 employees work together every day to make better care possible around the globe - one product, one partner, one patient at a time.
Under direct supervision, the Associate Regulatory Affairs Specialist for Safety assists the regulatory affairs specialists and managers to coordinate activities of clinical research being conducted within the central regulatory department, supporting the US Oncology Research network. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
Demonstrates fundamental understanding of US Oncology Research processes, business and operational goals. Collaborates with team initiatives and serves as support for senior members of the team to deliver action items and products to our sites, IRB and sponsor/CRO clients. Understands the importance of building relationships at McKesson with key stakeholder and business partners. Ensures accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Analyzes regulatory requirements, identify potential conflicts, and have thorough knowledge and ability to apply federal regulations and USOR policies. Maintains awareness, excellent comprehension and appropriate application of relevant regulations.
Assess Serious Adverse Event reports that are completed by the network sites. Use critical thinking skills to query the sites for missing or incomplete information that is needed for IRB submission and correct reporting. Process IND Safety Reports from all manners of submission - either electronic, through a sponsor safety portal or via paper. Make these reports available to sites so they are compliant with their oversight of the safety forms. Troubleshoot issues with the portals. Be available to speak about our centralized processes to internal and external clients. Maintain detailed records and metrics of SAEs and INDSRs processed.
Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation. Ensures all safety reports are managed compliantly with FDA regulations. Maintains compliance and integrity of the safety portion of the study trial master file in paper/electronic formats. Ensures file is continuously updated and prepared for audits. Provide local expertise to internal teams regarding serious adverse events and IND Safety Reports.
Manages, completes, reconciles and submits safety reports. Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines.
High level of competency with computer software, including databases and database management, spreadsheet applications, development and presentation of PowerPoint slides, and training/educational materials. Creates e-signature templates and coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through internal tracking systems. Coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through CTMS and other task tracking systems. Communicates daily with sites to get documentation completed. Escalates to manager for non-responsive sites. Reviews each document for regulatory compliance, accepts or rejects documents. Creates and executes regulatory strategies for clinical trial applications. Exercises good judgment when making decisions. Perform quality control of documents provided by sites.
Schedules and attends internal and external business meetings to capture accurate meeting minutes and action items.
Other duties as assigned
Minimum Job Qualifications
Bachelor's degree in related field
Typically requires 0-2 years of relevant experience
2 years of Clinical research knowledge
1 year regulatory specialist experience
1 year oncology experience
Handles day to day work challenges confidently
Is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change
Shows resilience in the face of constraints, frustrations, or adversity; demonstrates flexibility
Proficiency with computer systems and Microsoft Office (Outlook, Word, Power Point, and Excel) required.
Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them.
Discretionary decision-making and independent judgment skills.
Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadline
Must be precise, thorough, reliable, and perform daily activities with minimal supervision
Knowledge of clinical research process and regulations
Demonstrated analytical skills
Able to create ad hoc reports, tracking tools, and professional documents
Able to interpret and apply complex government regulations
Work is performed in an office environment. Requires significant interaction with clinical and corporate staff.
Regularly required to sit and use hands to finger, handle or feel. The employee is occasionally required to stand, walk and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. Requires vision and hearing corrected to normal ranges.
Must be authorized to work in the US. Sponsorship is not available for this position.
We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us. Apply to join our team and help shape the future of healthcare!
McKesson is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.
Join us at McKesson!
Internal Number: JR0055649
About McKesson Corporation
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.