GSK
Senior Director, Medical Information & Content Approval - Quality, Training and
GSK, Upper Providence Township, Pennsylvania, United States
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. 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. 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. 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. 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. Ensure training programs incorporate evolving industry trends, compliance standards, and best practices. Partner with internal stakeholders 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. 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. Maintain comprehensive documentation of vendor management activities. 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. Why You? Basic Qualifications: 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: Experience in digital transformation and technology solutions Prior leadership of cross-functional teams within a matrixed organization Strong understanding of Medical Information and content approval requirements 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 Business Acumen - ability to analyze external environment and translate to strategy Building relationships – ability to work effectively with others Ability to enable and drive change Agility - demonstrate capabilities to assess situation, flex and adjust as required Strong organizational and planning skills Strong decision-making, collaboration, and communication skills GSK is an Equal Opportunity Employer and is committed to creating an environment where our people can thrive and focus on what matters most.
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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. 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. 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. 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. 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. Ensure training programs incorporate evolving industry trends, compliance standards, and best practices. Partner with internal stakeholders 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. 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. Maintain comprehensive documentation of vendor management activities. 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. Why You? Basic Qualifications: 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: Experience in digital transformation and technology solutions Prior leadership of cross-functional teams within a matrixed organization Strong understanding of Medical Information and content approval requirements 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 Business Acumen - ability to analyze external environment and translate to strategy Building relationships – ability to work effectively with others Ability to enable and drive change Agility - demonstrate capabilities to assess situation, flex and adjust as required Strong organizational and planning skills Strong decision-making, collaboration, and communication skills GSK is an Equal Opportunity Employer and is committed to creating an environment where our people can thrive and focus on what matters most.
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