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  1. 1. Gloria Aung, BSc. (Hons) Medical Product Specialist 25 May 2005 The role of Medical Affairs
  2. 2. GlaxoSmithKline Australia Medical Directorate Patti Owen Clinical Compliance Manager Dr Michael Elliott Vice President Medical Director Merril Wenlock Personal Assistant Dr Malcolm Handel Clinical Pharmacology Unit Director Dr Carlo Maccarrone Head of Clinical Research Dr Ashley Bates Head of Discovery Research Dr Amanda Clark Head of Medical Affairs Dr Gerard Cudmore Associate Medical Director Tony Bourke & Ann Maccarrone Research Specialist (Diabetes) Suzie Bratuskins & Dipal Patel Research Specialist (Respiratory) Adrian Serone Clinical Pharmacology Scientist Christine Weston Head of Clinical Research NZ Andrew Hvizdos Head of Medical Affairs NZ
  3. 3. Medical Affairs department Org chart Head of Medical Affairs Amanda Clark New Products/AI CNS/Vaccines Respiratory Product Specialist Respiratory - GPs Gloria Aung Product Specialist Medical Therapy Manager Pam Stokes Gabrielle Formosa Senior Product Specialist Sonja Herges Administration Assistant Julia Lee Medical Therapy Manager Aaron Guttmann Product Specialist Birgit Beisner Senior Product Specialist Respiratory – Specialists Rod Stosic Senior Product Specialist Respiratory - GPs Maggie Chow Product Specialist Amber Grant Jenifer Nguy Product Specialist
  4. 4. Vision <ul><li>Medical Affairs unique contribution to GSK Business is our ability to acquire knowledge, evaluate it and disseminate it to enable appropriate business decisions </li></ul>
  5. 5. Key Responsibilities <ul><li>Successful commercialisation of key brands: provide expert scientific knowledge on our key prescription brands, competitors & the healthcare environment </li></ul><ul><ul><li>Input into brand strategy and development of promotional claims </li></ul></ul><ul><ul><li>Engage external stakeholders </li></ul></ul>
  6. 6. Key Responsibilities <ul><li>Promotional practices </li></ul><ul><li>ensure ethical and credible promotion of our key brands </li></ul><ul><ul><li>Promotional material review </li></ul></ul><ul><ul><li>GSK Business Essentials </li></ul></ul>Genital herpes campaign Erectile dysfunction campaign Asthma campaign
  7. 7. Key Responsibilities <ul><li>Protection of GSK’s brands and reputation </li></ul><ul><li>Manage issues which potentially threaten our brands to help maintain our competitive position in the marketplace </li></ul><ul><ul><li>Challenge strategy against competitors </li></ul></ul><ul><ul><li>Defence of challenges against GSK </li></ul></ul><ul><ul><li>Issues management </li></ul></ul>
  8. 8. Key Responsibilities <ul><li>Sales Force Effectiveness </li></ul><ul><li>Deliver scientific knowledge tailored to the sales representatives’ needs so that they can sell effectively, with confidence and credibility </li></ul><ul><ul><li>Training </li></ul></ul><ul><ul><li>Representative enquiries, presentations, memos </li></ul></ul>
  9. 9. Business Partners Medical Information Sales Regulatory Affairs Marketing Clinical Research Health Outcomes and Pricing External Customers Government and Public Affairs Medical Affairs
  10. 10. Skills <ul><li>Science, pharmacy or life sciences background </li></ul><ul><li>Team player </li></ul><ul><li>Communication skills </li></ul><ul><li>Training skills </li></ul><ul><li>Strategic </li></ul><ul><li>Commercial focus </li></ul><ul><li>Customer focus </li></ul><ul><li>Attention to detail </li></ul><ul><li>Writing skills </li></ul><ul><li>Presentation skills </li></ul>
  11. 11. Discovery Research coordinate and develop collaborative projects with researchers and innovators at hospitals, research institutes, universities, and companies across Australia James Lance GlaxoSmithKline Medicines Research Unit conduct early phase studies in a dedicated Clinical Pharmacology Unit, Prince of Wales Hospital, Sydney Clinical Research manage clinical trials and monitor sites participating in GSK-sponsored studies Regulatory Affairs work closely with government health authority to obtain and maintain registration of GSK products on the Australian Register of Therapeutic Goods Pharmacoeconomics analyse cost effectiveness data with the aim of listing GSK products on the Pharmaceutical Benefits Scheme Quality Assurance monitor and ensure that GSK products released onto the market meet quality specifications Clinical Supplies organise the distribution of GSK products for administration in clinical trials Biostatistics collate, analyse, and summarise clinical trial data Clinical Compliance perform audits to ensure that clinical trials are conducted in accordance with Good Clinical Practice Medical Information provide information to health professionals and consumers in order to ensure the appropriate use of GSK products Pharmacovigilance capture adverse event and pregnancy data in order to monitor patient safety, expand product knowledge, and comply with corporate and legal obligations Medical Affairs provide medical support and scientific input into brand strategies in order to ensure successful commercialisation of GSK products Sales establish relationships with health care professionals and provide them with current information on GSK products Marketing manage and implement brand strategies in order to ensure successful commercialisation of GSK products At GlaxoSmithKline Australia , Scientists can work in a variety of areas: We improve the quality of human life by enabling people to do more, feel better, and live longer