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GlaxoSmithKline LLC Sr. Manager - Office of CMO - Oncology in Collegeville, Pennsylvania

Reference #: 277594Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: Jan 27 2021The Senior Manager, Chief Medical Officer's Office, will ensure that the CMO (Chief Medical Officer) can fulfill and document all its duties and has appropriate oversight of all areas under the Medical Governance framework. This role is responsible for ensuring CMO oversight of critical issues related to patient and product safety (IMT/CMT process), Grants, Donations and Sponsorship activities for GSK and ensuring and documenting Rx-Vx CMOs compliance according to GSK policies and external guidelines/regulations.The Senior Manager role will coordinate with therapy areas to ensure that medical governance activities related to CMO oversight are conducted to the highest ethical, medical and scientific standards, in accordance with the relevant laws and regulations. The main objective of the role is to ensure that CMO oversight for medical governance activities related to Scientific and Health Care Professionals Engagements, Non-Promotional Material, Publication and Disclosure are in line with GSK policies and external guidelines/regulations.Why you?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 Vaccines Medical Governance Framework, encompassing significant issue and bioethical questions, organized along the different parts of the business: Oncology, Specialties, Vaccines; ensuring documentation of CMO approvals/exceptions.Ensures that the CMO has timely and regular documented oversight of the status of RandD compliance with GSK POLs, Governance systems and processes (cross-departmental, central and regional) and Issue escalation and management.Drives effective resolution by the CMO of Medical Governance issues or bioethical questions related to the conduct and disclosure of Human Subjects Research, Scientific and Health Care Professionals Engagements, Non-Promotional Material raised by the Medical Governance boards/Committees.Provides appropriate governance and oversight activities related to Grants, Donations and Sponsorship activities for GSK.Acts as Secretary for Medical governing bodies/committees and ensure that these governing bodies/committees fulfil their remit as defined in their respective charters.Provides transversal perspective across RandD 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 governing bodies/committees.Works transversally within RandD in order to implement the framework of medical governance activities to support the requirements of the business and evolving medical governance expectations.Coordinates with GMLT, Therapy area heads and other key stakeholders regarding progress and performance, and ensures follow-up of activities related to Scientific and Health Care Professionals Engagements, Non-Promotional Material.Coordinate the implementation and roll out of medical governance framework such as Managed Access Program, Bioethical curricula.Implements the Internal Control Framework (ICF) for Medical Governance and the Medical Platform, which encompasses Risk Management, Management Monitoring, Control Document, Training and Independent Business Monitoring.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor's Degree in Pharmacy, Chemistry, Bio-Engineering, Biology, Bio Medical SciencesExpertise in essential regulation guidelines and GSK medical governance policies and procedures applicable to RandD8 + years of experience in clinical research and/or in pharmaceutical industry, preferably in a related therapy area such as Oncology, Vaccines or Respiratoryexperience in governance-type activities with understanding of the commercial and compliance functionsExperience and