There is an increasing need to demonstrate and enhance patient outcomes, utilising Real World Evidence (RWE) as part of a therapy area’s overall integrated evidence generation strategy. It is also critical for internal decision-making, e.g. defining disease strategy, identifying population segments with more favourable benefit-risk, payor planning and input into trial design. RWE is defined as data generated from sources other than randomised controlled clinical trials, and includes electronic medical records, claims data-bases, registries, audits and prospective, non-interventional studies.
The purpose of this role is to proactively co-develop and co-lead the HEMAR implementation plan for immunology products in EMEA with a specific focus on driving and coordinating RWE plans, to improve the value proposition and sustain market access during the product lifecycle.
Consultant to Medical Affairs (MAF) and HEMAR on RWE across all Immunology therapy areas, with Compound Market Access Lead (CMAL) oversight
Contribute to integrated evidence generation (IEGP) strategy and tactic plans with Integrated Brand Value Teams IBVTs for EMEA Immunology, with CMAL and TAMAL oversight
Liaise with patient organisations in relation to RWE projects, including evaluation of Health Solutions
Secondary use of data RWE project ownership as agreed between MAF and CMAL/TAMAL
- Extended IBVT member across Immunology TA’s
TA expert member of EMEA RWE leadership team, contributing to Methods Review Board (MRB) and selected working groups, with TAMAL oversight
Can line manage a junior team member, if required
Generate and leverage RWE
As part of business planning and across all Immunology therapy areas, propose, drive and implement projects and actions to fill the gaps in the value proposition and that provide value to patients, providers and payers.
Proactively support HEMAR and MAF to develop robust strategic evidence generation plans that provide value to patients, providers and payers.
Consult to HEMAR and MAF on development and execution of RWE projects for promoted and pipeline products to meet evidence gaps
identify and shape research questions, design, methods and outcomes measurement, review and input to requests for proposals (RFPs),
review proposals and pitch presentations from external agencies, protocol and project report review and input,
discuss and support dissemination and publication plans.
Engage with patient organisations to collaboratively design and disseminate RWE plans, outcomes research and evidence generation projects.
Support OpCos in RWE, Pricing & Reimbursement negotiations, and other Market Access activities on an ad hoc and as needed basis.
Leverage activities and outcomes across OpCos and share best practices.
Work in close collaboration with Immunology CMALs to understand the perspective of the key HTA bodies across EMEA and their key evidence requirements, to proactively support HEMAR in filling those evidence gaps with the aim of achieving positive reimbursement for Janssen products.
Own and project manage delivery of RWE projects and work streams within specific prioritised areas across Immunology, for example patient-reported outcomes (patient preferences, health-related quality of life and health utility), epidemiology (disease prevalence, medical resource use, registry studies) or health solutions.
Manage external consultancy agencies in delivery of RWE projects and publications to support the business needs.
Ensure compliance with internal evidence generation and dissemination systems, including but not limited to, ReCAP, Smartform, JJAR, Pubstrat etc.
Maintaining Technical Knowledge
Review literature, refer to websites, subscribe to email alerts, attend webinars, conferences and courses to keep up to date on the current and future RWE landscape, methods and good practice, tools, data sources and external agency capabilities.
Attendance and contribution to cross-TA RWE best practice sharing and educational events in EMEA
Keep abreast of major changes in the health system across EMEA, including HTA/market access policies and discuss developments with colleagues to understand implications for RWE requirements across therapy areas and products.
Collaborate closely with MAF and Medical Affairs Operations (MAO) RWE colleagues to seek input and guidance on RWE data sources, process, internal and external governance issues, leveraging their expertise to support HEMAR and MAF with RWE project planning and delivery.
Collaborate with MAF and HEMAR to shape and develop robust RWE generation strategies, projects and dissemination plans.
Key RWE contact for HEMAR Functional Network questions and support requests
Together with CMAL, point of contact for global HEMAR colleagues for coordination of evidence generation and dissemination
- Extended IBVT member
Engage with and build relationships with academic experts, key clinicians, patient organizations, external agencies, real world data and health solutions providers to ensure that all RWE projects add value and meet customer needs.
Support the development of team processes to ensure that all work is conducted in accordance with appropriate local, EMEA and global SOPs.
Key Compliance Requirements
Complete all allocated compliance and SOP training in a timely way e.g. annual Drug Safety Training, and act according to guidelines etc., stated within these programmes and documents
When commissioning contractors or third-party organizations, put contracts in place and provide training so that these individuals also act in accordance with Johnson & Johnson HCC requirements when interacting with Healthcare Professionals and report adverse events and complaints.
Complies with designated SOP’s for the role
Acts in accordance with Johnson and Johnson HCC requirements if interacting with Healthcare Professionals
Adhere to team processes, ensuring that all work is conducted in accordance with appropriate local, EMEA and global SOPs.
Essential Technical Knowledge, skills and experience
- ≥ 5 years of experience of working in outcomes research, epidemiology and/or real-world evidence at a pharmaceutical company or consultancy at global, regional or operating company level
Good understanding of health economics and clinical research methodologies, epidemiology, outcomes research, biostatistics, meta-analyses, retrospective and prospective data generation activities, clinical trial methodologies, relative effectiveness and all other ingredients of an evidence generation strategy to build and maintain an optimal value proposition for the Janssen portfolio.
Good understanding of major European price & reimbursement systems and insight into the European HTA and price & reimbursement landscape, processes, requirements and interactions.
A post graduate qualification in outcomes research, epidemiology and/or real-world evidence or equivalent
Fluent in English (speaking and writing)
Ability to travel approximately 25-40% of the time
Europe/Middle East/Africa, Europe/Middle East/Africa-Switzerland, 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)