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 PurposeRepresents the Product(s) Technical/GTD expertise in the Global Product Team acting as the single project representative within own FunctionAct as subject matter expert acting as core team member of the Global product Team and, if applicable, as a leader of extended teamBe responsible for the delivery of Functional contribution to Product strategy development and executionSupport all GTD services and disciplines to understand projects, approaches, strategy to guarantee clear comprehension of the development and the requirementsMain ResponsibilitiesContribute 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 areaAct as the single Functional Area voice and reference within the Core Team and the single project representative within own FunctionEnsure GTD strategy definition with proper alignment and integration of pharmaceutical development and R&D development planAct as champion and advocate of the project within own FunctionGuarantee proper and full understanding of Functional area related activities to fulfill the Project needsForesee, anticipate and highlight risks/criticalities/impact on other functions following own Function proposals/resultsActively contribute to cross-functional project decisions with all CTMsBuild 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 teamEnsure leadership of Extended Technical team for the assigned project/sHelp 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 needsCollaborate in business case preparation and due diligence activities in projects involving more disciplinesExperience RequiredAt 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.
EducationScientific Master Degree
LanguagesTechnical SkillsRobust knowledge of pharmaceutical product development processKnowledge of ICH/GMP requirementsKnowledge of principles, approaches and planning toolsIn depth understanding of the regulatory requirements for product development and industry standardDirect experience from regulatory interactions related to CMC preferably with EMA and FDA.Proven experience with CMOs and CROsGood knowledge regarding GMP complianceAwareness of sustainability impact of development activitiesSoft SkillsLeadership and social influenceStrategic thinkingPlanning and organizational skillsWhat 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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