Director, Content Approval - Quality and Training

The Director, Content Approval - Quality and Training is a critical position within Global Medical Information and Content Approval. The Director will support the Sr Director of Quality, Training and Operations in the development, implementation and embedment of key training and capability initiatives to support the strategic objectives of content approval, including ABPI examination and certification and management monitoring.  The role requires strong leadership, decision-making, collaboration, vendor management, management monitoring and process implementation skills to enhance the efficiency, compliance, and effectiveness of content approval deliverables. The Director serves as a key partner for both Medical Affairs and Commercial organizations.   

Key Responsibilities:

Quality Oversight:

• Manage quality control processes (incl. established KPI and SLAs, where applicable) within content approval including ABPI examination and certification.
• Identify, assess, and execute/manage actions to mitigate risks associated with content approval operations.
• Review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives.  Recommend possible actions for continuous improvement.
• Engage with GMI CA Leadership, team members and key business partners identifying opportunities for continuous improvements, sharing performance metrics and managing risks & mitigations
• Assist as a subject matter expert on content approval process, serve as a key point of contact for audits, and inspections, and manage remediation efforts related to content approval.
• Develop and implement robust content approval management monitoring and ensure timely completion of relevant CAPAs.
• Act as the deputy global process owner for the process of approval of promotional and non-promotional materials and partner with the global process owner to ensure process is optimal and drive adequate understanding and application of the same to ensure high quality and compliant content at GSK. 

Training:

• Identify training needs and develop and deliver a comprehensive training strategy for Content Approval team members, ensuring alignment with internal processes and external regulatory requirements and business needs.
• Ensure vendors for content review and approval have the necessary training on relevant GSK requirements/processes.
• Develop, deliver and maintain a comprehensive onboarding curriculum for the Content Approval team members.
• Partner with ABPI Directors, GMI&CA leadership and internal stakeholders (e.g., Compliance, Legal, Regulatory, Commercial) to ensure training content remains current and relevant.
• Conduct refresher training on content review and approval process, as needed, to ensure high quality and compliance.

Why You?

Basic Qualifications:

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

• Master’s/Graduate Degree in Life Sciences or Healthcare
• 6+ years of pharmaceutical industry experience
• 3+ years of Medical Affairs experience
• Strong understanding of content approval requirements including external regulations (e.g. ABPI Code)
• Experience in quality and compliance oversight including audits and inspections
• Experience in the development and delivery of training and onboarding programs

Preferred Experience:

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

• Experience in digital transformation and technology solutions to enhance training and operations.
• Leadership experience in cross-functional teams within a matrixed organization.
• Experience of working at both global and local country level
• Flexible thinking - ability to analyze external environment and translate to strategy and gain support from others to implement a vision.
• Ability to analyze external environment and translate to strategy.
• Ability to work effectively with others, delegate appropriately and foster a strong culture of teamwork.
• Ability to execute and embed change initiatives
• Demonstrate capabilities to assess situation, flex and adjust as required to meet the demands of the business

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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