McKesson

Sr. Manager of Research Regulatory Affairs

McKesson • $110K — $130K *
US-AnywhereRemote in United States
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree required; Master's Degree preferred
  • Minimum 3 years of research experience (site-side or industry)
  • At least 3 years of management experience with direct reports
  • Research certification (ACRP or CCRP) preferred
  • Strong customer service and communication skills

Responsibilities

  • Oversee regulatory start-up and trial maintenance including safety and conflict of interest
  • Collaborate with research sites, study activation, protocol operations, and budget teams
  • Develop and implement regulatory policies and procedures for sites and Clinical Operations team
  • Manage regulatory affairs for multiple clinical trials per FDA and GCP guidelines
  • Lead problem-solving efforts with department managers and site leadership
  • Provide strategic direction and oversight for regulatory startup and maintenance
  • Assess and improve organizational processes related to regulatory startup and support

Benefits

  • Supportive work environment focused on employee development and recognition
  • Opportunity to lead and influence across multiple teams and departments
  • Access to career advancement through internal strategies and training programs
  • Engagement with industry partners and regulators to shape compliance practices
  • Participation in professional meetings and educational programs
Full Job Description
The Senior Manager for Research Regulatory Affairs is responsible for the overall operations of, which include but is not limited to Regulatory Affairs Specialist, Conflict of Interest, Safety, Process Specialist. This individual will also work very closely with study activation site research teams, protocol research operations, budget, and contract department, and finance to continue evaluating our regulatory processes and metrics to ensure regulatory is working as efficiently as possible to meet or exceed our goals. In this role, the individual must have managerial and leadership skills as well great customer service skills to comfortably interact and communicate with internal teams, pharma/CRO teams, IRBs, site research teams and our physicians. The Senior Manager:
  • Oversees the regulatory start-up and maintenance of trials; including safety and conflict of interest
  • Works closely with our research sites, study activation, research protocol operations, budget, and contracts team
  • Develops and implements 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
  • Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks • Manages 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
  • Problem solves with the department managers and other site leadership as they arise
  • Assists in developing and executing the Sarah Cannon internal and external strategies
  • Provides oversight, leadership, and direction in the regulatory study startup of trials and in maintenance areas where support is provided
  • Assesses organizational processes associated with regulatory startup and support to identify ways to improve and streamline processes
  • Meets with site leadership as needed to ensure contracted services are being provided by the teams
  • Accountable for leading people, setting direction, and deploying resources; responsible for attracting and selecting talent; support onboarding new employees to decrease time to productivity; driving performance through their team members by setting direction, providing feedback, and creating a trust-based, inclusive work environment; developing employees through coaching and feedback; rewarding and recognizing employees via ongoing recognition and core pay-for-performance practices are primarily achieved through the work of others and typically depend on the manager's ability to influence and negotiate with parts of the organization where formal authority is not held.
  • Develops metrics and reports KPI on weekly and monthly basis to department managers to ensure targets initiatives are being met.
  • Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation.
  • Provides leadership and direction to employees either through other managers or directly to employees.
  • Develops, adapts, and executes functional or departmental strategy to achieve key business objectives in area of responsibility.
  • Keeps executive and management team abreast of issues, progress, and risks related to regulatory affairs
  • Develops, implements, and evaluates programs to promote recruitment, retention, and continuing education of the team
  • Attends and participates in all required meetings including weekly operational review and Director's meeting
  • Assists in development and tracking of department goals and metrics
  • Works closely with monitors, sponsors/CROs, sites, and team to ensure quality and timely work being delivered
  • Support and collaborate with IRB counterparts to ensure quality relationships
  • Represents company vision to colleagues and external customers
  • Tracks and communicates to team and sites performance expectations and status
  • Works with other members in Research Operations to ensure communication and responsibility are effective and appropriate
  • Adhere to professional standards and SOPs established for clinical research and develop newSOPs and or Working Practice Guidelines as appropriate. Monitor adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.
  • Participate in educational activities and programs
  • Maintain strictest confidentiality
  • Provide proactive and creative recommendations on how to meet corporate and role-specific goals and handle identified deviations
  • Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management
  • Provide high level customer service, support and problem resolution to ensure the delivery of organizational goals


You should have for this position:
  • A Bachelor's Degree preferably a Master's Degree
  • At least three years of Research experience either on the site side or within industry
  • At least three years of Management with direct reports
  • Research certification (ACRP or CCRP) is preferred


About McKesson

McKesson Corporation provides medicines, pharmaceutical supplies, information and care management products and services across the healthcare industry. The Company operates in two segments. The McKesson Distribution Solutions segment delivers ethical drugs, medical-surgical supplies and equipment and health and beauty care products throughout North America. This segment also provides specialty pharmaceutical solutions for biotech and pharmaceutical manufacturers, sells financial, operational and clinical solutions for pharmacies (retail, hospital, long-term care) and provides consulting, outsourcing and other services. The McKesson Technology Solutions segment delivers enterprise-wide clinical, patient care, financial, supply chain, strategic management and software solutions. In July 2011, the Company acquired Portico Systems from Safeguard Scientifics, Inc. On March 25, 2012, it acquired the independent banner and franchise businesses of Katz Group Canada Inc. McKesson Distribution Solutions delivers pharmaceuticals to retail pharmacies and institutional providers like hospitals and health systems. They operate pharmaceutical distribution centers across the country, serving customers in all 50 states. They also deliver a comprehensive offering of health care products, technology, equipment and related services to the alternate site market, including physician offices, surgery centers, long-term care facilities and home care businesses across the country. McKesson is currently the largest pharmaceutical distributor in North America. McKesson also operates McKesson Canada and has an equity holding in Nadro, a leading distributor in Mexico.

McKesson Careers

Join McKesson, a leading global healthcare company, and be part of a team that is redefining the future of healthcare. With a variety of job opportunities available, McKesson is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At McKesson, we are committed to improving care in every setting—one product, one partner, one patient at a time. We’re seeking talented professionals to join our team and contribute to a culture of innovation, diversity, and leadership. Our employees are driven by a deep sense of purpose and a desire for continuous growth and improvement. Empower Your Future in Healthcare With positions ranging from internships to leadership roles, McKesson offers unparalleled employment opportunities to develop your skills and advance your career. Our commitment to diversity training ensures that all team members have the opportunity to thrive. Join a team where your skills will be honed, your professional growth will be supported, and where you can genuinely see the difference you make in the lives of patients around the world. Innovative Work Environment McKesson is at the forefront of healthcare innovation. Our team is constantly exploring new ways to improve patient outcomes and streamline care processes. This commitment to innovation is what sets us apart and what makes McKesson an exciting place to work. Career Development and Benefits McKesson believes in nurturing the potential of its employees through robust career development programs and comprehensive benefits designed to support your life and well-being. From leadership training to health and wellness benefits, we ensure our team members are equipped to meet their professional and personal goals. Explore Job Opportunities Whether you’re looking for an internship to kickstart your career, or a senior position to utilize your extensive experience, McKesson offers a range of opportunities. Explore our open positions and find where you can make a difference at McKesson. Stay Connected Join Our Team Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take the next step in their careers. Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Networking and Professional Growth At McKesson, networking and professional growth are part of our everyday environment. We encourage our employees to connect, share, and learn from each other to foster personal and professional development. Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await you at McKesson. Join McKesson today and be part of a team that is dedicated to shaping the future of healthcare.
Learn more about McKesson
Size
58,000 employees
Market Cap
$53.7 billion
Industry
Pharmaceuticals & Biotech
Net Income
-$4.1 billion
Founded
1833
5 Year Trend
+5.9%
Revenue
$237.6 billion
NASDAQ
MCK
* Ladders Estimates

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