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?
This position reports directly to the Clinical, Medical, Regulatory Affairs (CMR) Director and it is a people managing role of 2 team members.
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:
- Innovation in the development of RWE projects proposal in line with the affiliate / Region and IO needs
- Build the project from the idea, to the implementation throughout the approval process & Budget building
- Ensured projects are conducted in line with internal and external governance requirements, identifying best practices across the project.
- Supports relevant cross-functional alignment and project endorsement in projects.
- Engages with vendors, ensures expected deliverables and meets timelines / challenges on content for low or medium complexity projects
- Develops both internal and external facing communications on project progress / proposals (under instruction from CMR director)
- Identifies risks and mitigation actions in the process of execution.
- Identifies project metrics to secure high-quality deliverables.
- Completes the RWE study according to plan, securing adequate communication to direct internal and external stakeholders. Shares learnings with immediate team.
- 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
- Supports needs identification and priorities of stakeholders.
- Plans and executes stakeholders' engagement. Overcomes possible objections.
- Manage communication, contracting & project follow up with CROs &/or external vendor handling the RWE study execution &/or analysis
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
- Provide input to Study Outline
- Prepare Study Protocol, informed consent and amendments, if applicable
- Provide input to study and project related documents (e.g. CRF, CTR, Study Validation Plan)
- Ensure availability of other study related documents, e.g monitoring guidelines
- Plan and conduct Investigator meetings and other meetings incl. Investigator Result meeting(s)
- Ensure Audit and Inspection readiness
- Handling protocol deviations (if applicable) to ensure high compliance
- Ensure compliance with all existing applicable requirements, and overall ensuring compliance with GPP, GVP and other applicable external regulations for the non-interventional studies as well as Criteria for medical drug promotion and local regulations in the local meetings within and outside the study community.
- 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 secondary
Excellence 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 guidance
- 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 research
Work 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.
Working at Novo Nordisk
At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Manager before applying
Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.