Senior Director, Medical Information & Content Approval - Quality, Training and Operations

The Senior Director, Medical Information & Content Approval - Quality, Training, and Operations is a key leadership position within GMI & CA. This role will drive operational excellence, ensure high-quality of content approval through appropriate processes and monitoring. This role will also oversee key training and capability initiatives in GMI & CA to support the strategic objectives of the Medical Information and Content Approval (GMI&CA) department. This role will also be the global process owner (GPO) for content approval at GSK. The role requires strong leadership, decision-making, collaboration, vendor management, and process implementation skills to enhance the efficiency, compliance, and effectiveness of the GMI&CA department.

Key Responsibilities:

Quality Oversight:

• Oversee quality control processes within GMI&CA and vendors to support GMI&CA activities, ensuring adherence to company policies and external regulatory requirements.
• Oversee compliance monitoring, audits, and inspections, and manage remediation efforts.
• Partner with GMI&CA leaders and other business partners in regulatory inspections and audits related to GMI&CA activities. Ensure timely and effective responses to any findings.
• Lead the Accelerator medical review team in reviewing and overseeing the vendor for content review and approval of promo materials for digital only promotion for EU and GCI LOCs, as relevant.
• Oversee planning and implementation of management monitoring of content approval and timely completion of relevant CAPAs.
• Provide regular reports to senior leadership on quality performance, compliance status, and improvement initiatives.
• Act as the global process owner for the process of approval of promotional and non-promotional materials and engage with senior leadership at global and local level as well as cross-functional stakeholders to ensure process is optimal and drive adequate understanding and application of the same to ensure high quality and compliant content at GSK.
• Risk Management: Develop and implement strategies to identify, assess, and mitigate risks associated with MI CA operations.

Training:

• Oversee the development, implementation and delivery of a comprehensive training strategy for GMI&CA team members, ensuring alignment with regulatory requirements and business needs.
• Ensure training programs incorporate evolving industry trends, compliance standards, and best practices.
• Partner with internal stakeholders (e.g., Compliance, Legal, Regulatory, Commercial) to ensure training content remains current and relevant.

Vendor Management:

• Oversee the vendors for MI Contact Centres, MI Content, and Medical Review.
• Implement and monitor performance metrics and service level agreements (SLAs) to ensure vendor accountability and high-quality deliverables. Address any performance issues promptly. 
• Partner with Procurement for vendor selection, negotiations, contracting, and ongoing management.

Compliance And Risk Management:

• Ensure vendors comply with internal standards, regulatory requirements, and industry best practices. Develop and implement risk management strategies to identify, assess, and mitigate risks associated with vendor operations.
• Collaborate with vendors to identify opportunities for continuous improvement in service delivery including digital innovation.
• Maintain comprehensive documentation of vendor management activities, including contracts and performance reports.

Operational Leadership:

• Develop and execute operational strategies to achieve departmental objectives. Establish and drive key performance indicators (KPIs) to measure and improve operational effectiveness.
• Lead process improvement initiatives to enhance efficiency and compliance.
• Drive change management initiatives for the successful adoption of new GMI&CA solutions, processes and technologies.
• Facilitate financial discipline through oversight of resource allocation, including budgeting of variable costs, to ensure optimal utilization of talent and financial resources.

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master’s/Graduate Degree in Life Sciences or Healthcare
• 8+ years of pharmaceutical industry experience
• 5+ years of Medical Affairs experience
• Experience in quality and compliance oversight
• People leadership experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in digital transformation and technology solutions to enhance training and operations.
• Prior leadership of cross-functional teams within a matrixed organization.
• Strong understanding of Medical Information and content approval requirements incl. External regulations (e.g. ABPI Code)
• Experience of working at both global and local country level
• Experience in audits and inspections
• Flexible thinking - ability to analyze external environment and translate to strategy and gain support of others to implement a vision.
• Business Acumen - ability to analyze external environment and translate to strategy.
• Building relationships – ability to work effectively with others, delegate appropriately and foster a strong culture of teamwork.
• Ability to enable and drive change.
• Agility - demonstrate capabilities to assess situation, flex and adjust as required to meet the demands of the business
• Strong organizational and planning skills
• Strong decision-making, collaboration, and communication skills.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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