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

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

MediabistroUpper Providence, Delaware County, United States
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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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