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GlaxoSmithKline LLC Sr. Manager - Office of CMO - IMT/CMT in Collegeville, Pennsylvania

Reference #: 277602Site Name: Belgium-Wavre, UK - London - Brentford, USA - Pennsylvania - Upper ProvidencePosted Date: Jan 26 2021The Senior Manager, Issue Management Team (IMT)/ Crisis Management Team (CMT) will ensure that the CMO (Chief Medical Officer) can fulfill and document all its duties and has an appropriate oversight of IMT/CMT across all therapy areas.The position holder is responsible for ensuring CMOs oversight of critical issues related to the IMT/CMT process and ensuring documentation of CMOs decision according to GSK policies and external guidelines/regulations.The role will coordinate with therapy areas to ensure that IMT/CMT activities related to safety, rights and well-being of clinical study subjects, data integrity, product quality, reputation of the company that result in an IMT/CMT are conducted in accordance with the relevant processes and guidelines.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 oversight of CMO for IMT/CMT management across the different parts of the business: Oncology, Specialty, Vaccines; ensuring documentation of CMO approvals/exceptions.Organizes topics to be escalated to the Issue Management Core Team. Recommends (upon need) the initiation of an IMT/CMT following the relevant SOPs/guidance. Develops the agenda of the meetings, drafts minutes of the meetings, ensures appropriate review and approval of meeting minutes.Acts as escalation point for IMTs for GCP/GCLP issues. Assesses the regulatory and legal implications of the IMT/CMT, for e.g. impact to CSR, TMF, Regulatory submissions.Ensures tracking of actions and determines the extent of further investigation that is needed, including the need for internal and external communications (e.g. to regulatory authorities), as needed.Ensures IMCT decisions are communicated and implemented by RandD business with the support of subject matter experts as appropriate.Escalates to appropriate bodies within the organization - RandD RMB (RandD Risk Management Board), Enterprise Medical Governance Board(s), Clinical Development Quality Council (CQC).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.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 to support IMT/CMT activities and evolving medical governance expectations.Implements the Internal Control Framework (ICF) for IMT/CMT, which encompasses Risk Management, Management Monitoring, Control Document, Training and Independent Business Monitoring.Why you?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 Sciences8 + years of experience in clinical research and/or in pharmaceutical industry, preferably in a related therapy area such as Oncology, Vaccines or RespiratoryExpertise in essential regulation guidelines and GSK medical governance policies and procedures applicable to RandDExperience in governance-type activities with understanding of the commercial and compliance functionsExperience managing and driving complex transversal projects involving senior managementPreferred Qualifications:If you have the following characteristics, it would be a plus:Advanced Degree in Pharmacy, Chemistry, Bio-Engineering, Biology, Bio-Medical Sciences; or Medical Doctor (MD)Medical Governance qualificationBroad scientific/ pharmaceuti

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