Job title: Director Global Medical Ops & Governance
Company: The Medicines Company
Job description: Job Description “GH GMA” is 2 years old and we have gone from covering medical affairs in 46 countries in Sub-Saharan Africa (SSA), to being a key enabling partner in 7 GH programs, plus in our activities across Latin America and South-East Asia. In
Job Description ‘GH GMA’ is 2 years old and we have gone from covering medical affairs in 46 countries in Sub-Saharan Africa (SSA), to being a key enabling partner in 7 GH programs, plus in our activities across Latin America and South-East Asia. In this role, you will play an instrumental part in the GH GMA leadership team – focusing foremost on ensuring our frameworks for good governance and oversight are built with quality in mind, right from the start – and ensuring our medical operations (SEC&MI, data generation, early access), systems integration and risk management are audit-ready always. Become a part of the evolving and growing Global Medical Affairs team in Global Health: Your responsibilities include, but are not limited to: . Provide medical and scientific leadership into single or multiple medical brand teams as well as other brand related functions throughout the compound’s life cycle at global, region or country level. Support Global Medical Lead or region or country Medical Lead in the execution of medical activities. . Provide medical input on the evidence gap analysis and competitors’ landscape in conjunction with other functions (e.g. RWE, Drug Development) to support evidence generation decision making, as well as to drive activity planning, execution and reporting (interventional and/or non-interventional studies) . Perform key activities related to planning, execution and reporting of Medical Affairs studies and ensure timely and on budget delivery -Develop, contribute and review presentation materials for study/program-related advisory boards, investigator meetings, protocol training meetings, etc. -Serve as disease area medical expert for internal stakeholders from different line functions as well as external customers, including health care professionals, and patient advocacy groups . -Build together with Medical Lead the Medical Affairs strategy and plans, publications, internal and external educational activities as well as other communication activities involving Medical Experts -Provide capability building plan for field medical associates, including disease area and product specific content to train region or country CO medical associates -Provide medical scientific input for brand/program documents, including integrated disease area plans, Medical Information documents, Drug Safety reporting documents, etc . Review and approve promotional and non-promotional materials to ensure accuracy and appropriate compliance, according to Ethics and Compliance Professional Practices Policy (P3) -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt . Distribution of marketing samples (where applicable) Lead the Global Health GMA Operations and Governance function to enable Medical transformation, build capability able to adapt to dynamic environment and support vision. Lead the operations team to ensure strategic planning and delivery of the GMA plans across GH programs with high quality, adequate resources, timely and cost-effective execution. . Lead the Global Medical Affairs Medical and Scientific Engagement governance to develop and establish the governance and training strategy to monitor the adherence to Novartis GxP and P3 standards and manage compliance risks for Medical Affairs activities. Some of the KPIs of the role are as follows: . Timely execution and adherence to process is monitored through global KPls, KRI and KQI oversight . Compliance risks for assigned functions and activities are identified and managed with well-defined processes, appropriate internal level of controls across global, regions and local teams . Health Authority Inspections and internal audits have no critical findings for assigned functions and accountabilities . No financial or reputational impact or lost due to compliance issues for assigned areas Corrective And Preventive Action (CAPA) plans are effective, and are implemented and closed on time The incumbent will also be a GH Medical Leadership Team (MLT) core member, bring strategic view based on the integrated knowledge of Novartis units operations and strategy (GDD, NIBR, IM) and business needs across programs and markets . Works within Ethics and Compliance policies -Achievement of annual targets for medical activities. . Strategy Development People Leadership Collaborating across boundaries English Clinical Trial Design, Data & Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance Regulations & Guidelines[#video#https://www.youtube.com/watchv=ggbnzRY9z8w#400,300##/video#] Minimum requirements Educational requirements: . Advanced degree or equivalent education/degree in life science/healthcare is required. . PharmD/PhD preferred. Advanced knowledge in medical/scientific area required. MBA desired. Experience requirement: . 10 years of pharmaceutical industry, drug development and clinical operations experience with a proven track record of accomplishment at project or portfolio level. Experience in Medical Affairs desired . 5 years people management and development experience in global organization required, demonstrated leadership, project management expertise and accomplishment in operational aspects of clinical development . Demonstrated leadership and prior matrix management experience and ability to lead complex international multidisciplinary teams with a pragmatic approach . Strong understanding of clinical development activities andfunctions/roles/responsibilities and significant trial management experience and trial conduct accomplishment Applied Business Insights Business Mindset Digital & Technology Savvy Stakeholder Engagement Project Excellence Breakthrough Analysis Joint Value Creation Why Novartis 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons. Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Location: Mumbai, Maharashtra
Job date: Sat, 19 Mar 2022 23:20:54 GMT
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