Director, Medical Information & Content Approval, Vaccines

Role Summary

The Director, Medical Information & Content Approval, Vaccines plays a critical role in managing a team that ensures the US and global promotional and non-promotional content meets the highest standards of quality, scientific accuracy, balance, and compliance to inform clinical care and formulary access decisions. This role supports the Senior Director to develop and execute the Medical Information and Content Approval strategy, including innovative digital MI solutions, and serves as an influential partner to Medical Affairs, Commercial and other key stakeholders.

Responsibilities

• Lead and oversee the Global Medical Information and Content Approval Team for the Vaccines therapeutic area, acting as subject matter experts for their products.
• Contribute to development and execution of strategic priorities, including digital solutions, to meet stakeholder information needs.
• Lead and manage team performance, provide mentorship, and support development and problem resolution.
• Mentor and develop team members with training and tools, facilitating professional development through targeted plans.
• Act as a delegate of the Senior Director at leadership meetings as required.

MI and Content Approval

• Accountable for MI launch readiness plans, maintaining a robust MI database with medical insights to inform clinical decision making by HCPs.
• Stay up to date with ABPI Code of Practice and other regulatory guidelines; escalate as appropriate.
• Ensure thorough and timely review of promotional and non-promotional US and global materials for scientific accuracy, rigor, fairness, and compliance.
• Ensure MI requirements of the payer strategy for the U.S. are met.
• Partner with GMI Contact Centre directors to train MI CC staff on new products or data.
• Collaborate with Legal, Medical, Clinical, Regulatory, and Commercial teams to ensure high-quality, audience-relevant content.
• Support GMI&CA activities and onboarding of new team members as needed.

Cross-functional Collaboration

• Strategically partner with global TA and US medical stakeholders to align MI with medical strategy and needs of HCPs worldwide.
• Drive scientific exchange with external customers and manage MI activities at major Congresses using digital solutions.
• Represent Medical Information and Content Approval in cross-functional or medical leadership meetings related to 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: Experience in people leadership, management and development.
• Required: Experience working in a highly dynamic, changing, and matrixed environment.
• Preferred: Experience communicating and translating evidence to matrix partners; ability to develop innovative, customer-focused medical solutions.
• Preferred: Global and local country level experience, vaccines experience, stakeholder influence, and strong understanding of international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI).
• Preferred: Experience reviewing and approving promotional and non-promotional content; strong stakeholder relationship skills; strong clinical literature evaluation and communication skills.