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Director, Medical Affairs Operations

Position Summary:

The Director of Medical Affairs Operations provides leadership by developing and/or facilitating business processes utilizing staff and technology to create the highest level of efficiency, productivity, and success possible within the Medical Affairs (MA) organization. In addition, the individual serves as a member of the Medical Affairs Leadership Team.

 

Essential Functions:

  • Standard Business Practices (SBPs)
    • In conjunction with senior management, establishes methods, procedures, processes, and best practices to be utilized within the MA organization
    • Collaborates across departments to ensure MA SBPs are harmonized, as appropriate
  • Planning & Project Management
    • Supports financial planning and analysis of programs and initiatives including budgeting, program reviews, forecasting, and long range planning
    • Supports VP, Medical Affairs with the execution of strategic projects and facilitation of department team meetings
  • Vendor Management
    • Provides oversight of the contracting and purchasing programs, ensuring a consistent and efficient approach to negotiating, contracting, requisitions, purchase orders, invoices, reconciliation, and accounts payable
  • Information Systems (technology)
    • Responsible for developing, implementing, and managing the MA information systems strategy
    • Works collaboratively with senior management and IT to develop multi-year technology solution roadmaps in support of business and data analytic needs
  • Transparency Reporting
    • Collaborates with Legal, Regulatory Affairs, Commercial and other parts of the organization to ensure compliance with aggregate spend and Physician Payments Sunshine Act reporting activities
  • Library Services
    • Coordinates processes for ensuring availability of scientific material including journal articles and abstracts through the establishment of an e-library function while maintaining the highest level of compliance and copyright considerations
  • Compliance
    • Ensures all department policies, procedures, and systems are in compliance with internal and external regulatory and compliance guidelines
  • Team leadership and collaboration
    • Develop and manage team members, including hiring, talent management, succession planning and performance management
    • Ensure training and development of team members, and work to identify and provide formal and informal training for other stakeholders regarding MA processes and compliance
    • Forecast and propose resource allocation plans as well as manage resources within budget
    • Establish collaborative working relationships with functions outside of MA including, but not limited to: Clinical Development; Regulatory Affairs; Portfolio & Project Management; Finance; HR; Legal; IT; Drug Safety; and Commercial to optimize the financial, technical, compliance, and strategic management of key functional areas

Preferred Experience:

  • Minimum 8-12 years of relevant experience in a corporate setting with an emphasis on operations
  • An in-depth understanding of Phase IV/post-marketing drug development is preferred (knowledge of or experience with Phase I-III drug development is a plus)
  • Experience with the strategy and implementation of information technology solutions particularly related to Customer Relationship Management (CRM) systems
  • Understanding of Physician Payments Sunshine Act reporting requirements

 

Preferred Education:

  • Advanced degree such as Master of Science, MBA, MD, Pharmacy, PhD

 

Preferred Additional Skills:

  • Strong communication, presentation and business partnering ability
  • Demonstrated ability to build strong customer relationships
  • Ability to effectively handle multiple tasks and priorities in a fast-paced environment
  • Strong interpersonal skills and ability to work with others in a positive, collaborative manner
  • Ability to work well on cross-functional basis internally and with business partners
  • Proficient computer skills, including Microsoft Word, PowerPoint, and Excel
  • Proficient in various communication / collaboration platforms including Gmail, Google Calendar, Slack, Hangout, Box, Google Docs and Sharepoint
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive
  • Current US work authorization required
  • Ability to travel domestically and internationally
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