The Real-World Evidence Manager role will contribute to the general coordination and implementation of the RWE strategic plan in the EMEA region.
The successful candidate will be part of the RWE team within the Health Economics Market Access and Reimbursement (HEMAR) EMEA group, working closely within the RWE team, with the EMEA RWE community (RWE functions, HEMAR, Medical Affairs, the Operating Counties RWE managers, etc) to support building a regional centre of excellence in setting up scientific standards for RWE research.
Install, facilitate and ensure close information and learning sharing on RWE topics, across TAs, across geographies and within the HEMAR community (act as the glue on RWE methodology sharing between across teams, and between local and regional groups.)
Responsible for developing and coordinating capability building activities in alignment with the RWE strategy
Provides consultancy to local and regional teams in the development and execution of their RWE projects, connects teams to Janssen resources and expertise to ensure high quality efficient RWE projects
Maintains the RWE Guidebook in line with company SOPs, and industry best practices
Preparation of materials and metrics on RWE internal activities to update senior management
Leads or contributes to specific work streams required to deliver on the RWE strategy and priorities
Engages with external projects, partnerships and societies to represent Janssen as a leader in RWE, ensures leverage of external insights to develop robust scientific evidence, support RWE training strategy
Ensuring safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOP’s (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors;
Ensuring HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.
Advanced degree in a relevant RWE field (e.g. Pharmacoepidemiology, Outcome Research, Public Health, Statistics)
Experience and/or ability to learn conducting RWE projects for pharmaceutical products
Experience and/or ability to learn intermediate to advanced expertise in RWE Methodologies and project implementation
Other key skills:
Demonstrable leadership experience skills to manage in cross-functional settings
Excellent communicator and with strong business acumen
Proactive attitude and customer-focused
Past work experience:
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
Good general understanding of private and public RWE sources in the EMEA region
Knowledge of drug development (pre-clinical, clinical and post-marketing) and experience with ICH GCP guidelines
Language requirement: Fluency in written and spoken English - fluency in additional EMEA languages would be beneficial