Digital Regulatory Project Senior Specialist
4 settimane fa
Date: 8 Oct 2024 Department: Global Regulatory Affairs Team: RD, Pharmacovigilance Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, 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.
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 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 RD team represents a fundamental asset for the business.
It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, RD project and portfolio management.
Who we are looking for Purpose Ensure coordination and management of regulatory digital projects and initiatives during each phase (discovery, planning, execution, launch and maintenance) Ensure adequate execution of cross functional projects, participate on project team as expert in regulatory digital project management Main Responsibilities Ensure proper project planning and execution for digital regulatory initiatives with the development of detailed project plans, timelines, and budgets and coordination of project activities, ensuring tasks are assigned, tracked, and completed on schedule.
Monitor project progress and identify potential roadblocks, risks and interdependencies, providing timely updates to the Project Lead and Sponsor.
Drive and promote agile methodology across the organization.
Ensure effective communication within Global Regulatory Affairs (GRA), cross-functional teams, and other internal/external stakeholders.
Organize and lead regular project meetings, creating agendas, and documenting action items to drive decision making and project execution.
Provide status reports and project updates to Project Lead and relevant stakeholders.
Prepare progress reports, including status reports and risk registers, and contribute to post-implementation reviews to assess project success and lessons learned.
Collaborate with the Unit Head to allocate resources appropriately for project tasks, monitor resource utilization, and ensure team members have the necessary tools and support to accomplish their tasks.
Track project related costs to ensure alignment with overall project budget.
Ensure project deliverables adhere to regulatory guidelines and quality standards.
Support change management initiatives, including SOP updates, associated with digital tool implementation and business initiatives.
Identify potential risks and issues that may impact project success and work with the Project Lead to develop mitigation strategies and engage appropriate leads to find a resolution.
Experience Required Minimum of 7 years experience in Regulatory Affairs.
Project Management experience preferred.
Good knowledge regulatory data and processes as well as digital implementation projects.
Education Life Science Degree Post graduate degree preferred Languages English: fluent Technical Skills Good knowledge of Regulatory Affairs procedures Advanced Knowledge of IT Proficiency in project management tools and software.
Understanding of digital tools and technologies used in regulatory affairs Soft Skills Analytical skills Communication skills Team working Planning and organizational skills 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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