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Team: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Europe - remote, IT
About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 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: Discover more here We are proud to be the largest global pharmaceutical group to be awarded 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.
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 Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).
Who we are looking for Purpose The CRP contributes to the clinical development of the respiratory pipeline by authoring and validating scientific documents relevant to clinical studies (e.g.: study protocol, case report form, Investigator's Brochure, clinical study report, publications, etc.), and representing the Company in front of advisory boards and institutional authorities. The CRP is a member of the Study Team using his/her clinical / therapeutic expertise to increase technical knowledge and competencies across functions.
Main Responsibilities • Acting as a member of the Clinical Study Team, deliver the results of the assigned Clinical Studies and the related Key Clinical Documents, in accordance with the Clinical Development Plan and the related agreed timelines (e.g. clinical section of the investigator's Brochure, assigned Protocols, Protocol amendments case report form, data review report, and Clinical Study Reports, etc.).
• Provide the clinical input to functional portions of the Clinical Development Plan (study design, regulatory interactions) with attention towards the timely and quality execution of the plan through interaction with Study Team Members.
• Establish an appropriate medical and study protocol training for the study team and selected CRO. Establish a medical monitoring plan with the selected CRO for the assigned studies. Provide oversight of medical monitoring activities.
• Ensure the safeguard of Patients Safety: in collaboration with and in support of Pharmacovigilance, identify safety signals, review narratives, lend appropriate and sound medical interpretation, and take actions with investigators and/or data safety monitoring boards when Serious/unexpected Adverse Events are reported, ensure a full understanding of key Adverse Events and Serious Adverse Events and appropriate actions.
Experience Required A significant experience in clinical or academic research. At least 3 years in clinical drug development preferred although equivalent expertise in clinical academic research will be considered.
Experience within the respiratory therapeutic area.
Education Medical Doctor Degree; certification in Respiratory Diseases/Pulmonology will represent a plus
Languages Technical Skills Experienced in writing protocols/reports, preparing clinical development plan, reviewing literature, authoring the clinical sections of the investigator's brochure (IB), Data Safety Update Report (DSUR), and regulatory documents. Ability to interact with academic and regulatory experts with confidence, integrity and persuasion. Proficiency in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance Proficient in MS Office (Word, Excel, PowerPoint), Adobe and Outlook. Soft Skills Adaptability and flexibility Goal orientation Problem solving Stress management 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 to 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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