Real World Evidence Manager
1개월전에
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
Position
This position reports directly to the Clinical, Medical, Regulatory Affairs (CMR) Director and it is a people managing role of 2 team members.
Job Summary
The Manager, RWE Science & Innovation leads the development and execution of RWE strategic initiatives and specific programs for the assigned therapeutic areas or function areas through customer engagement, communication, advanced analytics. Specifically, this role will be focusing on Obesity business area.
The incumbent acts as a strategic partner and leads customer engagement in assigned therapeutic area with NNPK and APAC stakeholders within Clinical, Medical and Regulatory (HEOR Strategy and Evidence Generation, Research Partnerships, Field Medical, Market Access and Public Affairs, as well as a liaison to therapeutically aligned IO/APAC counterparts in Epidemiology, Data Science and Real-World Evidence.
The manager communicates the RWE strategy and project's execution to internal and external stakeholders on behalf of RWE team and NNPK as well as serves as an advisor on real world data, advanced analytics and real-world evidence methods. S/he manages partner relationships, vendors and strategic collaborations on behalf of RWE team and NNPK. The Manager serves as the therapeutic area team or function area leader in the execution of specific in-house real world data studies across the entire Novo Nordisk portfolio utilizing the Novo Nordisk data platform as well as working with external platforms housing real world data (including electronic health records, administrative health claims, as well as uniquely sourced health data). Conduct analyses using internal and external real world data to generate unique disease insights and epidemiological information to improve patient care and support business needs Drive innovation in RWE analytics by implementing new analytic methods, platforms and technologies to answer research and business questions
Main tasks include:
Project management
People management
Manage the RWE team (provide coaching, mentorship and managerial support) in order to facilitate the process of strategic implementation, anticipating barriers and challenges to achieve and exceed business expectations Participate in people management processes applying the provided tools in order to recruit, hire, develop, engage and retain high contributors Deliver clear directions and leadership support to the RWE team members in order to achieve organizational goals and to ensure the team executes against the strategy, regulation and standard operating procedures of Novo Nordisk
Internal and external stakeholder management
Other task areas - Real world study management
Project and stakeholder management
Manage communication effectively with the Core Team/Study Group, CRO and affiliate Create a plan for operational management of real world studies, incl. Gantt Chart and ensure timely deliverables Implement and use project management tools, e.g. communication plan and risk management plan Coordinate timely delivery of relevant components of documents to IRB/IEC incl. relevant communication with affiliates and other relevant stakeholders (ie. CRO) Ensure timely deliverables from stakeholders outside Medical Affairs e.g. Global Safety Ensure close communication on study progress (sharing of relevant recruitment timelines, decisions, updates and alignment of expectations) with Core Team members and other relevant skill types Prepare, update and follow up on study budget(s); develop budget guideline for affiliate and APAC/ IO or HQ budget Vendor /Clinical Research Organisation selection and management Share learning and best practice
Study Operations
Coordination
Protocol writing coordination: hold kick off with internal stakeholders/protocol writers (internal or external), coordinate whole process to approval. Focus on Primary data as limited process for secondaryExcellence in Execution
Lead the collection of data and the analysis of actionable medical insights to support strategic business decisions Drive the development of the KOL List, KOL Engagement Plan and Scientific Communication Plan as aligned with the strategic priorities across focused therapy areas Identify needs, changes and trends within the business environment in order to adapt and improve strategic planning and implementation Support internal organizational readiness through RWE team members in product knowledge trainings and medical communication guidanceEducation requirements
Ph.D or Masger's degree in relevant biotherapeutic areas (health economics, epidemiology, biostatistics, data science, predictive analytics, health services research) Preferably Ph.D in Health economics & Outreach researchWork experience & qualifications
Well-balanced experience of medical affairs and clinical operation/development is required Global MNC (Experience working with global teams) is highly preferred Min. 2 years of work experience in real world data analytics Min. 3-5 years of pharmaceutical industry experience needed Peer-reviewed publication track record is a plus. Excellence communication skills & English fluency Experience working with longitudinal RWD assets (e.g., claims, electronic health records, and/or surveys) is a plus Experience in the conduct of non-interventional research is a plus Experience in using statistical software (e.g., R, SAS, Python, SPSS, and/or Stata), database query (SQL) or visualization tools (e.g., Tableau) will be an advantage Collaborative approach to problem-solving and ability to plan and multi-task.-
South Korea Novo Nordisk 풀타임The position The RWE Manager reports to the CMR Director, manages 2 team members, and in charge for developing and executing RWE initiatives and programs for assigned therapeutic or functional areas, with a focus on Obesity. The role involves leading customer engagement and serving as a partner to Novo Nordisk Pharmaceuticals Korea (NNPK) and APAC...
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South Korea Novo Nordisk 풀타임The position The RWE Manager reports to the CMR Director, manages 2 team members, and in charge for developing and executing RWE initiatives and programs for assigned therapeutic or functional areas, with a focus on Obesity. The role involves leading customer engagement and serving as a partner to Novo Nordisk Pharmaceuticals Korea (NNPK) and APAC...
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