Senior Strategic Technical Leader

1 mese fa

Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

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.
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.
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 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 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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