Director, CMO Office Management and Oversight, Global Health

仕事内容

Site Name: Belgium-Wavre, UK - London - Brentford

Posted Date: Jan 12 2023

As Director of Chief Medical Office (CMO) you will ensure that CMO can fulfil and document all its duties and has an appropriate oversight of all areas under the Medical Governance framework related to Global Health.

You are responsible for ensuring CMOs oversight of critical issues related to patient and product safety, Grants, Donations and Sponsorship activities for GSK, manage access program, research conduct and disclosure and ensuring and documenting CMO compliance according to GSK policies and external guidelines/regulations.

You will coordinate with the Global Health team to ensure that medical governance activities related to CMO oversight are conducted to with high ethical, medical and scientific standards, in accordance with relevant laws and regulations, such as activities related to conduct of Research, Scientific and Health Care Professionals Engagements, Non-Promotional Material, Publication and Disclosure as well as managed access program are in line with GSK policies and external guidelines/regulations as well as to support the team in leveraging the appropriate ethical approach in the different Global Health projects

Key Responsibilities:

• Supports Medical Governance oversight of CMO for Medical Governance Framework, encompassing issue management, organized along the different parts of Global Health, ensuring documentation of CMO approvals/ exceptions.
• Ensures that the CMO has timely and regular documented oversight of the status of Global Health compliance with GSK POLs, Governance systems and processes including progress and performance (cross-departmental, central and regional) and Issue escalation and management.
• Supports the elaboration of the Global Health 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, Grants and donations, Managed access program raised by the Bioethical Committees or panels.
• Acts as OCMO point of contact and connection point between the Global Health team with the Risk Management team in OCMO (Office of the Chief Medical Officer).
• Provides transversal perspective across Global Health 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 medical governance bodies/committees.
• Supports the deployment of Corporate Policies impacting CMO activities. Connect the relevant Global Health Subject Matter Expert (SME) to ensure proper coordination of the review/update, implementation and roll-out of GSK Policies with the Policy team.
• Supports the Internal Control Framework (ICF) implementation for Global Health team. Ensures Internal Audit preparations as appropriate. Presents the findings including ensuring the CAPAs are in place and provide a resolution to the findings. Escalate to the appropriate enterprise risk team any identified risk.
• Maintains an up to date and in-depth knowledge of appropriate national and international regulatory legislation and guidelines; and the impact to Global Health area processes and procedures. Additionally, ensure intelligence is utilised for continuous improvement of inspection management processes.
• Educates, guides and influences Global Health 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?

BasicQualifications:

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

• Master’s degree in Pharmacy, Chemistry, Bio Engineer, Biology, Medical Doctor, Bio Medical Sciences plus 8 years of relevant 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 or Immunology
• Relevant experience in governance type activities with understanding of the commercial and compliance functions
• Previous experience to implement change management projects with proven track record
  
  

Preferred Qualifications:

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

• Knowledge and understanding of R&D environment, policies and procedures and applicable regulation requirements.
• Good understanding of GSK Organization (GSK Corporate, GSK Pharma, GSK Vaccines and Global Health) strategy. Able to make link within GSK organization.
• Good understanding on the supranational organisations and collaboration setting.
• Good Bioethical mindset. Able to substantial and leverage various bioethical options in autonomy.
• Ability to navigate in the different legal framework around collaboration and donations.
• Ability to incorporate strategy & organizational considerations and to operationalize them.
• Proven sense of urgency.
• Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills
• Excellent communication and presentations skills, ability to facilitate interfaces within an extended network, proven experience in negotiating and influencing at different levels of the organization.
• Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment.
• Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside GSK
• Act as a role model in line with GSK core values, behaviours and ambitions
• Comfortable to evolve in changing and challenging environment.
  
  

Why GSK ?

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.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using the science of the immune system, human genetics and advanced technologies to get ahead of infectious diseases, HIV, cancer and immune-mediated and respiratory diseases. We do all this with a commitment to operate responsibly for all our stakeholders by prioritising Innovation, Performance and Trust.

Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and treatments, including innovative new products, will reach more people who need them more than ever before.

We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That’s why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.

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 our ambition for GSK to be 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 people 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.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

We’re also working hard to become more inclusive in the way we do business. We’re building demographic planning into our clinical trials, so they reflect the real-world population that’s affected by the disease we’re studying. We’re engaging with diverse-owned suppliers that meet our standards and share our values. We’re also inspiring the next generation of diverse scientists by investing in STEM education programmes to improve career opportunities for people in under-represented communities.

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.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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