• Prior drug development experience with good knowledge of GCP regulatory/ market access and reimbursement requirements.
• Ability to develop, design and implement Phase 3b /4 studies.
• Experience in Medical Affairs and life cycle management preferred, including understanding of launch support requirements.
• Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
• Good networking, communication and influencing skills to work effectively in a complex matrix environment.
• Demonstrated ability to build strong internal and external networks.
..... continued - Part II of Regulatory Affairs Job Offering at GSK for Darapladib
GSK’s new global franchises are born of this once in a lifetime opportunity. In order to be ready to launch these new products, this year and beyond, we have undergone a major change initiative to re-design the way we support and manage evidence generation for and commercialisation of our portfolio of late stage medicines, thereby better connecting the earlier stage development activities with later stage programmes and the markets on a global basis. This dramatic transformation, leading to a major expansion, has been driven by our core values; transparency, respect for people, patient-focus and integrity.
As part of this exciting initiative, we have a number of truly outstanding opportunities for medical affairs leaders to join our Global Franchise teams. These positions demand not only deep technical content expertise but highly credible strategic insight and the willingness to fundamentally transform the future. We are committed to your development,, and offer an intellectually stimulating and rewarding environment, enabling you to realise your full potential.
As Scientific Manager, Darapladib, reporting to the Global Medical Affairs Leader (GMAL) , your role will be to support the consolidation of input from multiple internal and external stakeholders, and develop the Integrated Evidence Strategy & Plan for their asset with input from R&D, Health Outcomes, etc. In addition, you will be responsible for supporting the planning and execution of all GSK studies from phase IIIB onwards, including post-approval commitments – as well as implementing assigned elements of the global Medical Affairs Plan.