Team: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Europe, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.
We are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.
What we are looking for
Purpose
Improving the lives of patients through innovative clinical research.
Main Responsibilities
• Develop and execute the implementation of patient engagement strategies in the assigned disease area/clinical study with the aim to refine the clinical development plan, the protocol design, and the study operational execution.
• Identify and contribute to the implementation of global or regional initiatives for promoting innovation in clinical research that can enhance the study efficiency, data quality, and patient experience.
• Drive the implementation of DEI (Diversity, Equity and Inclusion) tactics and strategies in the assigned disease area/clinical study.
• Drive the execution of strategies and initiative to improve patient recruitment, retention, and adherence in clinical studies.
• Act as the main point of contact between R&D Patient Engagement and internal functions (Clinical Programs, Clinical Operations, Patient Advocacy, Communications, Public Affairs, Core Team, Regulatory Affairs, R&D Departments, Legal&Compliance).
• Maintain or lead relationships with patient engagement organizations.
• Stay current with regulatory guidelines and industry trends related to patient engagement and innovation in clinical research.
• Map and update SOPs and KPIs to embed patient engagement in R&D activities.
• Manage budget and cross-functional teams as appropriate.
Experience Required
• 3+ years of experience in R&D patient engagement departments. 5+ if experience has been acquired by working on projects with the patient communities in other departments.
• 5+ years of experience in clinical research in Pharmaceutical, Contract Research Organization (CRO) or other clinical trial sponsor environment.
• Extensive knowledge of clinical research operations across multiple study phases (Phase I-IV) and GCP guidelines.
• Comprehensive understanding of drug development process.
• Passion for improving the lives of patients through innovative clinical research.
Preferred:
• Strong experience in writing and editing health and science communication documents.
• Experience in communicating complex scientific ideas to the general public in clear, concise language.
• Proven track record of implementing digital innovations in clinical trials and developing effective patient engagement strategies.
Education
• Bachelor’s degree in scientific or healthcare discipline or relevant field.
• Advanced degree in scientific or healthcare discipline or relevant field is a plus.
Languages
Soft Skills
- Customer orientation
- Emotional and social intelligence
- Goal orientation
- Planning and organizational skills
- Quality orientation
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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