We have an exciting opportunity for experienced Epidemiology scientist to support Real World Evidence project in early stages of development.
•Identifying and prioritizing opportunities to optimize the development and differentiation potential solutions using robust, stage-appropriate RWE.
•Being accountable for the implementation and delivery (execution, interpretation and communication) of the RWE Strategic Plan within the respective therapeutic area.
•Developing and driving the RWE input to the development of regulatory plans and associated documents (e.g., submissions, RMP, PIP, PSP, ODA, etc.), medical affairs plans, and HEOR/patient access plans as required.
•Representing RWE on functional teams within the Mission(s) (e.g., Medical Team, Patient Safety, Regulatory, Market Access, Commercial/Marketing, Core Launch Teams, etc.).
•Supporting optimization of the regional and country RWE strategic plans through close collaboration with the RWE Business Liaison, RWE Regional Partners, and local HEOR/RWE Leads (as appropriate)
•Collaborating with thought leaders and external research partners to develop real-world data to inform decisions of HCPs, clinical organizations, reimbursement authorities, and regulatory agencies.
•Ensuring alignment of RWE tactics with the Strategic Publication Plan
•Masters degree (ideally a PhD) in Epidemiology, Outcomes Research or other relevant scientific discipline, and have a track record of publications in high-caliber peer-reviewed journals.
•Pharma experience with a proven successful track record of impactful use of Real-World Data (primary and secondary data) in partnership with, Regulators, Payers, HTA bodies, and Outcomes Researchers.
•Hands-on experience in working across internal stakeholder functions (e.g., medical affairs, market access, clinical development, etc.) to develop the optimal RWE strategy and tactical plan to support an asset within a specific disease area or focus.
•Track record of performing high quality research (i.e. scientific publications; abstracts, posters, full papers in peer-reviewed journals).
•Leadership skills, including mentoring and coaching and building teams.
•Possessing good communication, stakeholder management, and influencing skills as well as a desire and experience in developing transversal ways of working.
•Combination of strong methodological quantitative knowledge, strategic thinking, and communication skills
•Strong background knowledge of industry trends, best practices, and external stakeholders expectations of RWE, specifically related to epidemiology/outcomes research, regulatory affairs and market access.
•A subject matter expert, able to balance the need to think strategically with the need to deliver stage-appropriate high impact results.
•Proven ability to write/edit scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.).
This is a permanent opportunity and there is flexibility to work from home. As the client is a global pharmaceutical company with offices based in the UK, Germany, Belgium the role can be located in one of their European locations.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.