Director, Cmo Office Management and Oversight
il y a 2 semaines
Site Name:
Belgium-Wavre, UK - London - Brentford
Posted Date:
Jan
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.
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 (crossdepartmental, 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 rollout 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 indepth 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?_:
Basic Qualifications**:
- 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,
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