McKesson Regulatory Manager, REMS in Scottsdale, Arizona
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.
We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise. Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
Join our team of leaders to begin a rewarding career.
The Risk Evaluation Mitigation Strategies (REMS) Regulatory Manager will support FDA submission activities and REMS Assessments across existing customer programs and potential pharmaceutical, biotech and generic manufacturer customers. This individual contributor will participate in the REMS group to lead, manage and produce expert deliverables in support of FDA consulting, submission preparation, medical writing, and assessment activities.
He/she is a capable professional with medical writing expertise and REMS experience, who will participate in activities supporting:
FDA REMS Program Consulting Design and Submissions
FDA REMS Assessments including: Surveys, Stakeholder Audit activities, Data analysis and management, Assessment Report narrative development.
This individual should possess strong FDA, clinical, and operational acumen. Experience managing senior- and executive-level relationships, single sponsor and multi-sponsor engagements are desirable. This individual should possess strong analytical and problem solving skills, capable of delivering multiple projects on time and within scope. Additionally, this individual will be highly skilled working in a matrix environment.
Client Solutions - May help to obtain or support new consulting engagements with clients. Contributes to most appropriate FDA submission or Assessment metric design to meet the clients’ goals/needs. Collaborate with Business Development, REMS Operations, Customer Management, and Director of REMS Strategy to deliver comprehensive, high-quality consulting deliverables. Participates in conferences and team meetings as appropriate, may attend client and/or FDA meetings to represent solutions.
Customer Management - He/she provides business management and REMS strategic expertise to program teams and/or customers. He/she supports Customer Managers (CM's) to achieve the goals of delivering quality FDA deliverables to clients. Attends client meetings as required to deliver projects, improve profitability, quality and/or client satisfaction. Adhere to Quality Management standards and processes and provides guidance to the team to assure continued adherence. Help to ensure the coordination and execution of timely and effective internal and external communication. Ensure client touch points are provided professionally and on time.
Team Contribution - Participates on teams to complete objectives on time and within budget. May collaborate with other McKesson Business Units to deliver comprehensive solutions for clients as appropriate; may include RelayHealth, McKesson Specialty Canada, etc. Develop subject matter expertise on the REMS product line, customer programs and marketplace.
Primary Support for external party audits (i.e. clients and regulatory authorities), in accordance with Quality Management system.
5 years of related experience. Desired backgrounds may include healthcare, Medicare, pharmaceuticals, biologics manufacturing, or clinical research
Experience of Risk Evaluation Mitigation Strategies (REMS)
Previous experience with authoring/drafting submission documents and assessment reports; analyzing data to access effectiveness of Programs (REMS preferred or similar).
3 years of experience working in a FDA-regulated environment
Working knowledge of regulatory affairs, FDA regulations; (with GMP or GXP preferred)
Strong time management, organizational, analytical, research, writing, and editing skills
Additional Knowledge & Skills
• Pharmacovigilance/Drug Safety, Regulatory Affairs, Clinical Research, and/or Health Economics Outcomes Research (HEOR)
MS preferred or 4-year degree or equivalent experience
25% travel may be required
Location – Scottsdale, AZ office or remote may be an option
Environment (Office, warehouse, etc.) – Normal office environment
Physical Requirements (Lifting, standing, etc.) – Normal office environment requirements
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.
Job Family Title: Regulatory Affairs Specialist3
Organization: McKesson Specialty Health
Title: Regulatory Manager, REMS
Requisition ID: 18003323
Other Locations: United States-United States (Remote)