This position is an exciting opportunity to achieve and maintain optimal Market access across EMEA for Spravato®.
The HEMAR Manager SPRAVATO will be specifically responsible for co-leading the HEMAR evidence generation strategy for Spravato for TRD and MDSI in the EMEA region and for the implementation of important projects, thereby frequently handling multiple projects simultaneously, working closely with stakeholders and customers as well as supporting Local Operating Companies.
The position offers the candidate a lot of room for broader strategic thinking, thinking outside the box, and creative solutions, thereby broadening his/her data generation, project management and market access experience. Janssen Neuroscience has a very exciting pipeline which also offers a lot of opportunities in the longer term.
- Collaborate with IBVT key representatives and key countries to develop a compelling integrated evidence generation strategy that meets the need of payers and differentiates SPRAVATO® in a robust way considering the role of alternative strategies including RWE projects and database analysis
- Co-lead the HEMAR RWE strategy for SPRAVATO® within the EMEA region and the co-ordination with the Operating Company
- Take accountability for developing and substantiating the value proposition of SPRAVATO® across the product lifecycle through the RWE projects collaborating effectively with Operating Companies to create a compelling value dossier
- Proposing, driving and implementing all necessary RWE projects and actions to fill the gaps in the value proposition and optimizing the MA situation of SPRAVATO®, including working with relevant partners/stakeholders outside the company
- Supporting Operating Companies in RWE projects on an ad hoc and as needed basis
- Provide input into the concept, design and development of observational study protocols to ensure appropriate and scientifically sound methods on study design and analysis are being used.
- Leveraging RWE activities and outcomes across countries and focus on sharing best practices
- Provide HEMAR expertise into development of relevant study documents including ReCAP processes, development of study protocols and Statistical analyses plans
- Contribute to study reports and drive publications
- Takes responsibility for coordinating with cross functional teams in the assembly of project teams based on project priority, skill sets required, and resource availability.
- Works closely with the IBVT and the countries to ensure alignment and joint accountability for successful achievement of project goals.
- Reviews project team deliverables to ensure quality (deliverable walk-through, quality assurance results, etc.) and adherence to standards and requirements, including corporate compliance.
ESSENTIAL KNOWLEDGE & SKILLS:
Advanced degree in a relevant RWE field (e.g. Epidemiology, Health Economics, Public Health, Statistics) preferred.
Solid project management skills
Solid knowledge/experience in in conducting evidence generation projects for pharmaceutical products.
Solid understanding of Clinical research methodologies, meta-analyses, retrospective and prospective data generation activities, relative effectiveness and all other aspects that are essential in creating an optimal value proposition and professional HTA or price & reimbursement submissions.
Ability to create alignment across functions and geographies and work constructively with diverse groups in a complex matrix.
Excellent networking, listening, presentation, negotiation and scientific writing skills.
Understanding of pharmaceutical organizational processes, including experience working cross-functionally with internal and external stakeholders.
Familiar with health technological assessment methodologies and trends in public sector.
Knowledge of drug development (pre-clinical, clinical and post-marketing) and experience with ICH GCP guidelines.
Ability to think out-of-the-box and propose creative and solid solutions for very complex problems.
“Make it happen” and “roll up the sleeves” mentality, drive and motivation, persistence to achieve goals, and real team player.
Open to change with a flexible attitude to be able to handle a complex, multiple stakeholder environment, both internally and externally.
Seeing the big picture without losing analytical focus with an eye for detail as needed
Experience and ability to manage multiple projects with competing priorities to meet project deadlines
Excellent written and spoken English. Fluency in additional EMEA languages would be beneficial.
Aware of and adherence to J&J Credo values, SOPs, policies and guidelines.
Solid experience in performing real world outcomes research in a pharmaceutical environment. Market Access & Health Economics experience is a plus.
The role is Central Europe based and will involve travel (<40%) within the home country and across the EMEA region. It is anticipated that the role holder will be based in his/her current country of residence as long as easy access to travel/transportation and local hosting is available at a Janssen office.
Europe/Middle East/Africa, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom
Janssen Pharmaceutica N.V. (7555)