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Position
Patient Engagement Manager
Responsible
Therapeutic Development Director (TDD)
Contract duration
CDI full time
Salary
34 000 to 38 000 € for one full time equivalent
Location
EURORDIS Headquarters Paris
Plateforme Maladies Rares, 96 rue Didot, Paris 14ème, France
Main scope of the position:
In the area of therapeutic development, EURORDIS is recognised for its credible network of more
than 650 member patient groups in 61 countries and over 200 highly involved volunteers, as well as
its ability to advocate at the European level on behalf of rare disease patients. EURORDIS is
recognised for its major contributions toward the adoption of the EU Regulation on Orphan
Medicinal Products (1999), EU Pharmaceutical Review (2003), EU Regulation for Paediatric Use of
Medicines (2006), EU Regulation on Advanced Therapy Medicinal Products (2007), the Commission
Communication “Rare Diseases: Europe’s challenges” (2008), the Council Recommendation for
Action on Rare Diseases (2009) and the EU Directive on Patient Rights to Cross Border Health Care
(2011). EURORDIS plays an active role in the EU decision making process through its implication in
several Scientific Committees and Working Parties of the European Medicines Agency as well as the
Commission Expert Group on Rare Diseases and on Cancer Control. EURORDIS has established a long
term and fruitful dialogue with most pharmaceutical and biotech companies involved in therapy
development for rare diseases.
The Operations Unit is in charge of all research, registries, biobanks, therapeutic development,
information and access to medicines, social services, health and social research and patient service
activities of EURORDIS. As of early 2015, the Operations Team comprised twelve persons within a
EURORDIS total staff of 30. The position of Patient Engagement Manager is an update/enlargement
of a position created in 2008 in the context of the recruitment of a Therapeutic Development
Manager. This update aims at addressing the challenges of an increasing number of orphan medicinal
products and innovative therapies for rare diseases, the increasing involvement of EURORDIS in the
life cycle of the product from orphan designation, clinical development, protocol assistance, premarketing access, marketing application, risk management programme, registries, public information
to patients, real access for patients, as well as the increasing involvement of EURORDIS in the new
opportunities for patient engagement, parallel scientific advice/ Health Technology Assessment
(HTA), early dialogues, public/private partnerships… For these reasons this position will not be
dedicated to Therapeutic Development only but to all aspects of Rare Disease Therapies, including
information and access. The Patient Engagement Manager is supervised by the Therapeutic
Development Director and will liaise with the Treatment Information and Access Director, Health
Policy Advisor, with the Senior Manager of Relations with Patient Organisations, with the Training
Manager to ensure the link with the Capacity Building programmes and with the EU Public Affairs
Manager, in charge of the global activity of the EURORDIS volunteers.
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Main missions of this position and main areas of responsibility are:
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To help coordinating the EURORDIS’ activities related to the development and access to
medicines for people living with rare diseases in Europe – orphan medicinal products but also
paediatrics, gene and cell therapies, etc.
To manage the process of patient engagement in Research & Development and beyond,
through the different types of procedures by identification, invitation, exchange,
information, training, support and follow-up of the EURORDIS patient representatives.
To help managing the work of the EURORDIS volunteers/advocates involved in TAG –
Therapeutic Action Group.
To manage documents/bibliography in relation with EURORDIS’ action in the field of
therapeutic development and market access.
To update the communication to EURORDIS members regarding documents prepared by the
European Medicines Agency and/or the European Network of HTA Agencies (EUnetHTA)
Key tasks:
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Download and filing of folders received from the EMA or other entity, in relation with the
activities of EURORDIS in the Scientific Committees and Working Parties of the Agency, as
well as in HTA initiatives, etc.
Review of the EMA documents on orphan medicinal products for lay public in collaboration
with the EMA staff, such as the COMP Public Summaries of Opinion at the time of
designation.
Organisation and support to patient representatives’ participation as experts in the different
evaluation procedures of medicinal products (EMA activities, other type of patient
engagement such as HTA bodies, EU projects): Identification of patient experts and support
with administrative requirements (Declaration of Interest, Confidentiality Undertaking, travel
and accommodation). Currently the main activity is related to the engagement of patient
representatives in the Protocol Assistance procedures and in parallel Scientific Advice / HTA
assessment, but this may evolve in the future with the engagement of patient
representatives in Risk / Benefit Assessment, Health Technology Assessment, Payers value
assessment and reimbursement.
Communication to EURORDIS members or regulatory / HTA documents of interests (new
orphan drug designations, new marketing authorisation applications, CHMP opinions on the
marketing authorisations, renewals, withdrawals or suspension, PRAC and CHMP agendas
and minutes, EMA monthly letter to stakeholders, European Public Assessment Summaries,
Risk Management Plan Summaries, Safety warnings, Questions & Answers documents,
Medicines requiring additional Monitoring (black symbol), Information on shortages…) which
may include update of EURORDIS website, e-news, social media…
Follow-up the engagement of patients by making the link with the online community
platform RareConnect (https://www.rareconnect.org/fr) and by entering and managing
records in the EURORDIS Contact database for all patient representatives.
Organisation and support to the TAG (Therapeutic Action group) activities in close relation
with the TDD. Organisation of the monthly conference calls including taking minutes and
sending reports, help with organising annual face-to-face meeting with the EURORDIS Board
including travel and accommodation, follow-up on participation of the TAG members to the
Scientific Committees and Working Parties of the EMA and on reimbursement claim forms
for each TAG members.
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When needed, direct communication with EMA staff to follow-up on procedures,
information, reimbursement issue, invitations status…
Management of internal Call for Expression of Interest and preparation of the application to
EC calls for Expression of Interest to involve patient representatives in the Scientific
Committees and Working Parties of the EMA and other institutions.
Contribute to the preparation and dissemination of the monthly EURORDIS Therapeutic
reports.
Any other tasks in the scope of the position
Skills and capabilities
Languages: Fluent English speaker. Working level in French. Another European language will
be a plus.
Education: Minimum 5 years education in science, biology, pharmacy, or medicine.
Work experience: Experience in an international environment in the health sector. The
candidate needs to demonstrate excellent communication and proactive skills.
IT: Fully operational with Word, Excel, Power Point
Qualities:
o Ability to work with patient advocacy groups and to support the work of volunteers
(patient parents, professionals) to empower them. Minimum required will be to
demonstrate ability to work closely with a wide variety of persons, to be openminded, curious, to have proactive relationship, to show empathy and to build social
relationship.
o International and inter-cultural profile
o Commitment is essential in this position: concerned or really stimulated by rare
diseases or other chronic medical conditions.
o Team worker and Autonomous: multi-tasker, able to work under pressure.
Logistics: Available to travel (~ 10 to 20% of the time) to support meetings at the EMA,
organise or attend EURORDIS meetings and trainings all over Europe.
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