Date: 16 Aug 2024
Department: GTD Global Technical Development
Team: R&D, 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 (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, global technical development, 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), Toronto (Canada) and Shanghai (China).
Who we are looking for
Purpose
Represents the Product(s) Technical/GTD expertise in the Global Product Team acting as the single project representative within own Function
Act as subject matter expert acting as core team member of the Global product Team and, if applicable, as a leader of extended team
Be responsible for the delivery of Functional contribution to Product strategy development and execution
Support all GTD services and disciplines to understand projects, approaches, strategy to guarantee clear comprehension of the development and the requirements
Main Responsibilities
Contribute to shaping and optimising the Global project strategy in collaboration with GPL, DL and the rest of the Core Team, acting as SME for the reference functional area
Act as the single Functional Area voice and reference within the Core Team and the single project representative within own Function
Ensure GTD strategy definition with proper alignment and integration of pharmaceutical development and R&D development plan
Act as champion and advocate of the project within own Function
Guarantee proper and full understanding of Functional area related activities to fulfill the Project needs
Foresee, anticipate and highlight risks/criticalities/impact on other functions following own Function proposals / results
Actively contribute to cross-functional project decisions with all CTMs
Build and lead the (cross or extended) team with right competences to deliver the functional plan and/or work packages supporting to the product(s) strategy agreed with project team
Ensure leadership of Extended Technical team for the assigned project/s
Help all GTD services/disciplines to understand projects plans and related strategies, to guarantee proper and full understanding of development and GTD related activities to fulfill the needs
Collaborate in business case preparation and due diligence activities in projects involving more disciplines
Experience Required
At least 8 years in R&D GTD of pharma company and/or CRO/CDMO. Highly experienced in leading and managing internal and external activities and stakeholders. Experience from regulatory interactions with EMA and FDA, as well as other regulatory authorities.
Education
Scientific Master Degree
Languages
English fluent
Technical Skills
Robust knowledge of pharmaceutical product development process
Knowledge of ICH/GMP requirements
Knowledge of principles, approaches and planning tools
In depth understanding of the regulatory requirements for product development and industry standard
Direct experience from regulatory interactions related to CMC preferably with EMA and FDA.
Proven experience with CMOs and CROs
Good knowledge regarding GMP compliance
Awareness of sustainability impact of development activities
Soft Skills
Communication skills
Leadership and social influence
Strategic thinking
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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