Medical Governance and Operations Manager

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Nov 23 2022 Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Job Purpose and Key Responsibilities: The key purpose of this role is to contribute to the reduction of organizational risk related to Non-promotional Engagement and Promotional Practices within the Medical Division and to provide operational support for certain office based Medical Affairs activities (e.g. copy approval, medical information, Medical Excellence, Medical operations, abridged prescribing information management etc.). Medical Governance Responsibilities: Work with the Senior Manager - Medical Gov and Ops to identify risks associated with Non-promotional activities within the Medical department. Support the Senior Manager - Medical Gov and Ops for ensuring business operations are assessed to identify Medical Governance risks, and these risks (and mitigation plans) are tracked in a Risk Register. Ensure Management Monitoring for Non-promotional activities within Pharma Medical department is conducted as per the Management monitoring schedule agreed with the CMD. Track completion of CAPAs. Ensure execution of the CAPAs related to the findings from the Independent Business Monitoring and Independent Assurance and external inspections related to Non-promotional activities within Pharma Medical Department (in consultation with the Senior Manager - Medical Gov and Ops). To keep up to date with changes to GSK Medical Governance processes and ensure appropriate implementation in India as required (in consultation with Senior Manager - Medical Gov and Ops). To be the Business Contact for implementation and management of global medical written standards at a local level. Follow-up on all Management Monitoring (MM), Independent Business Monitoring (IBM), Scientific Engagement & Medical Affairs (SEMA) assessments and Internal Audit preparations for the group. Review all the existing and new processes are being implemented and used in line with our GSK policies, Code and SOPs Medical Operations responsibilities: Review and approve promotional materials for products/teams (as agreed with the CMD). Ensure fulfillment of Medical Information enquiries (which are out of scope of MAPS (Medical Information and Pharmacovigilance services) Ensure medical review of local Prescribing information for GSK pharma products as and when requested by the regulatory team. Ensure update and maintenance of local abridged prescribing information for GSK pharma products (subsequent to PI update). Ensure timely medical review of requisitions for GSK sponsored or organized meetings in order to ensure compliance with all applicable SOPs (for India only). Ensure execution of the medical engagement plan through enhanced data collection, establishing milestones and tracking progress, and identifying potential obstacles and alternative solutions. Continually evaluate and drive refinement of best-in-class processes; implement new innovations/technologies with demonstrated ability to simplify complex procedures to drive performance for the assigned field medical teams. Optimize interactions between the Medical Affairs teams and key matrix partners by assessing the needs and complexities. Accountability: Scope: Accountable for ensuring high standards of Medical Governance within Pharma Medical Division for Medical Affairs and MI activities. To protect and enhance the reputation of GSK Pharma through high standards of Medical Governance, failure of which will have an adverse impact on business. Complexity: Requires in-depth understanding of processes outlined in local and global Written Standards (applicable to the role) Requires collaborative working with LOC commercial/regulatory teams as well as above country personnel. Need to maintain thorough knowledge of Indian laws pertaining to marketing practices. It is imperative to keep abreast of all changes and adapt quickly, in the context of evolving external regulations and GSK policies related to promotional practices and scientific engagement. Emphasize to the commercial and medical teams the relevance and importance of medical governance in order to protect GSK’s reputation and provide timely solutions (where possible) to business requirements within the framework of governance. Job Success Measures: Feedback from internal stakeholders and senior management No major compliance deviations in processes where the Medical Governance and Operations team are responsible Specialized Knowledge: Basic Requirements: Post-graduate degree in science or graduate in medicine Adequate and relevant pharmaceutical industry experience Ability to network with internal stakeholders and develop a working relationship with them Competent knowledge of web based tools Competent IT skills relevant to the job (e.g. Word, PowerPoint, Excel) Adherence to timelines Keen eye for detail Problem solving attitude and analytical skills. Good communication skills Preferred Requirements: Prior experience in medical affairs Proficient presentation skills At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. *LI-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 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. 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