Site Name: Belgium-Wavre, GSK HQ, USA - Pennsylvania - Upper Providence Posted Date: Aug 22 2024 Are you looking for an opportunity to manage and implement safety processes aligned to medical governance and policies while working across diverse cultures and environments? If so, this is the role for you. As Medical Governance Director you will be responsible for working with subject matter experts to deliver a simplified process and written standards that reflect GSK values as well as regulatory and legal expectations. As a content expert you will also be required to focus on safety processes and written standards received daily and from Senior Directors. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Supports Medical Governance oversight of CMO for Medical Governance Framework, encompassing issue management (IMT/CMT), organized along the different parts of the business, ensuring documentation of CMO approvals/exceptions. * Ensures that the CMO has timely and regular documented oversight of the status of R&D compliance with GSK POLs, Governance systems and processes (cross-departmental, central and regional) and Issue escalation and management. * Supports the manage access programs. * Drives effective resolution by the CMO of Medical Governance issues related to the conduct and disclosure of Human Subjects Research, Scientific and Health Care Professionals Engagements, Non-Promotional Material, Managed access program raised by the Bioethical Committees or panels. * Provides appropriate governance and oversight activities related to Grants, Donations and Sponsorship activities for GSK. * Acts as OCMO point of contact and first line support for bioethical consultancy questions. * Set-up, coordinate and manage Issue Management Team with cross functional Sr leaders. * Provides transversal perspective across R&D projects by maintaining a global view on development programs for medicines/ vaccines and ensuring liaison and alignment of recommendations/decisions between departmental and/or cross departmental Bioethical Committees or panels. * Works transversally within R&D to implement the framework of medical governance activities to support the requirements of the business and evolving medical governance expectations. * Coordinates with functional LTs, Therapeutic area heads and other key stakeholders regarding progress and performance and ensures follow-up of activities related to Conduct and disclosure of research, Scientific and Health Care Professionals Engagements, Non-Promotional Material. * Supports the proper management of Corporate Policies impacting CMO activities. Connect the relevant Subject Matter Expert (SME) to ensure proper coordination of the review/update, implementation and roll-out of GSK Policies with the Policy team. * Maintains an up to date and in-depth knowledge of appropriate national and international regulatory legislation and guidelines; and the impact to the therapeutic area processes and procedures. Additionally, ensure intelligence is utilised for continuous improvement ways of working processes. Only complete documents can be evaluated. By submitting this JE form you acknowledge that the +1 Manager has given approval. Job Evaluation at GSK Submission link Job Evaluation Form Version control April 2018 GCO1 * Educates, guides and influences Therapeutic area management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility. Assists in developing and maintaining training programmes and help deliver training within area of expertise. * Ensures a sustainable, controlled, cross departmental remedial plan is in place and that decision making is applied in a consistent manner across similar issues. Ensures a mechanism of lessons learned is in place to share with appropriate stakeholders within the organization. Why you? Qualifications: * Bachelors degree in a scientific discipline * Expertise in essential regulation guidelines and GSK medical governance policies and procedures applicable to R&D. * 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. * Relevant experience in governance type activities with understanding of the commercial and compliance functions. * Good understanding of external Codes of Practices. * Proven experience of managing and driving complex transversal projects involving senior management. * Proven experience to implement change management projects. If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. 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). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. 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. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.