Medical Governance Director

4 days ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled and experienced Medical Governance Director to join our team at GlaxoSmithKline. As a key member of our organization, you will play a critical role in ensuring the effective management and implementation of medical governance processes across our business.

Key Responsibilities
  • Medical Governance Oversight: Provide strategic guidance and oversight to the CMO on medical governance framework, including issue management, to ensure compliance with regulatory and legal expectations.
  • Regulatory Compliance: Ensure timely and regular documented oversight of R&D compliance with GSK policies, governance systems, and processes, and issue escalation and management.
  • Project Management: Drive effective resolution of medical governance issues related to human subjects research, scientific and healthcare professional engagements, non-promotional material, and managed access programs.
  • Governance and Oversight: Provide governance and oversight activities related to grants, donations, and sponsorship activities for GSK.
  • Change Management: Implement change management projects to drive business improvement and ensure alignment with evolving medical governance expectations.
  • Stakeholder Management
  • Knowledge Management: Maintain an up-to-date and in-depth knowledge of national and international regulatory legislation and guidelines, and ensure intelligence is utilized for continuous improvement of processes.
  • Training and Development: Educate, guide, and influence therapeutic area management and staff on best quality and compliance policy and practices, and assist in developing and maintaining training programs.
  • Lessons Learned: Ensure a sustainable, controlled, cross-departmental remedial plan is in place, and that decision-making is applied in a consistent manner across similar issues.
Requirements
  • Qualifications: Bachelor's degree in a scientific discipline.
  • Experience: Broad scientific/pharmaceutical industry background with more than 8 years of experience in clinical research and/or in pharmaceutical industry, preferably in a related therapy area such as oncology, vaccines, and respiratory.
  • Skills: Expertise in essential regulation guidelines and GSK medical governance policies and procedures applicable to R&D, and proven experience of managing and driving complex transversal projects involving senior management.
  • Knowledge: Good understanding of external codes of practices and ability to maintain an up-to-date and in-depth knowledge of national and international regulatory legislation and guidelines.
About GSK

GlaxoSmithKline is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.

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