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Director, Medical Information & Content Approval, Vaccines

GSK
Full-time
Remote friendly (Durham, NC)
United States
Medical Affairs

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Role Summary

The Director, Medical Information & Content Approval, Vaccines leads a team to ensure US and global promotional and non-promotional content meets high standards of quality, scientific accuracy, balance, and compliance to support clinical care and formulary decisions. The role supports the Senior Director to develop and execute MI and Content Approval strategy, including digital solutions, and partners with Medical Affairs, Commercial, and other stakeholders.

Responsibilities

  • Lead and oversee the Global Medical Information and Content Approval Team for Vaccines, serving as subject matter experts.
  • Contribute to development and execution of strategic priorities, including digital solutions, to meet stakeholder information needs.
  • Manage team performance, provide mentorship, and support development plans.
  • Mentor and develop team members with appropriate training and tools.
  • Act as a delegate of the Senior Director at leadership meetings requiring TA-specific attendance.
  • Accountable for MI launch readiness plans and maintaining a high-quality MI database to inform clinical decision making by HCPs.
  • Stay up to date with ABPI Code of Practice and regulatory guidelines; assist team and escalate as needed.
  • Ensure thorough and timely review of promotional and non-promotional materials; content is scientifically accurate, rigorous, fair-balanced, and compliant.
  • Ensure MI requirements of the US payer strategy are met.
  • Partner with GMI Contact Centre to train staff on new products/data.
  • Collaborate with Legal, Medical, Clinical, Regulatory, Commercial to ensure high-quality content relevant to the audience.
  • Support GMI&CA team activities and onboarding new team members as required.
  • Strategically partner with global and US medical stakeholders to align MI with medical strategy and needs of HCPs worldwide.
  • Facilitate scientific exchange with external customers and drive MI excellence at congresses with digital solutions.
  • Represent MI&C A in cross-functional or medical leadership meetings/forums for the TA area.

Qualifications

  • Required: PharmD, MD, PhD, or equivalent.
  • Required: 6+ years in the pharmaceutical industry.
  • Required: 4+ years in medical writing and/or promotional review and approval.
  • Required: 4+ years in customer-focused problem-solving and conflict resolution roles.
  • Required: People leadership, management, and development experience.
  • Required: Experience working in a dynamic, matrixed environment.
  • Preferred: Experience translating evidence for matrix team partners and developing innovative, customer-focused medical solutions.
  • Preferred: Experience at global and local country levels.
  • Preferred: Experience in Vaccines.
  • Preferred: Influencing stakeholders to fill scientific data gaps; strong understanding of international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI).
  • Preferred: Experience reviewing and approving promotional and non-promotional content.
  • Preferred: Ability to build strong relationships with internal stakeholders; strong communication skills.
  • Preferred: Strong clinical literature evaluation skills and problem-solving abilities.

Skills

  • Scientific acumen and ability to maintain up-to-date knowledge of regulatory guidelines.
  • Leadership and people development capabilities.
  • Strong collaboration and cross-functional influencing skills.
  • Excellent written and verbal communication; strategic thinking.
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