Chiesi Group

Translator

• Supportare il team nelle attività di traduzione e revisione della documentazione tecnica ed operativa in lingua inglese ed italiana
• Collaborare con gli autori dei documenti e con i reparti coinvolti (Produzione, Qualità, Ingegneria, Manutenzione) per comprendere correttamente contenuti, terminologia e processi
• Garantire coerenza terminologica ed allineamento tra le versioni italiane ed inglesi dei documenti
• Supportare il monitoraggio dei processi di revisione e aggiornamento della documentazione all'interno dei sistemi documentali aziendali
• Contribuire al miglioramento continuo della documentazione
• Affiancare il team nella gestione e archiviazione della documentazione cartacea ed elettronica
• Partecipare alle attività di verifica della conformità documentale richieste dalle normative di settore

Intern – Manufacturing Documentation Translation

Data Specialist

• Assicurare la corretta creazione, manutenzione, governance e qualità dei master data di Plant
• Garantire l'allineamento tra processi, sistemi e requisiti di business lungo l'intero ciclo di vita del prodotto
• Agire come punto di riferimento per gli aspetti di Master Data Management del sito
• Supportare il corretto funzionamento dei processi di Planning, Procurement, Produzione, Qualità e Logistica
• Creazione, manutenzione e aggiornamento delle anagrafiche materiali e delle BOM di stabilimento
• Gestione del ciclo di vita del dato anagrafico, dalla creazione all'obsolescenza
• Garanzia della qualità, coerenza e integrità dei dati master di Plant
• Supporto alla definizione e all'evoluzione degli standard di Master Data Governance
• Calcoli e analisi sui KPI di competenza relativi a qualità e tempestività dei Master Data

Master Data Specialist

Manager

• Lead, mentor, and manage a team of LSD MSLs
• Conduct regular performance evaluations and set objectives
• Oversee recruitment, training, and onboarding of new MSLs
• Develop and implement strategic plans for the MSL team
• Collaborate with senior management to align MSL activities with broader strategies
• Foster and maintain relationships with KOLs and stakeholders
• Ensure MSLs effectively communicate scientific information
• Monitor and analyze MSL activities for compliance
• Review and approve MSL reports and presentations
• Work closely with other departments to support integrated strategies
• Provide insights based on interactions with healthcare professionals and KOLs
• Prepare and present regular reports on team performance

Manager, MSL, Global Rare Diseases

Account Manager

• Create awareness around rare disease states based on company marketed product(s) of focus
• Business development and prospecting
• Strategic account management – ability to translate strategy into action
• Target, plan and work consistently through all states and regions of the geography
• Manage leads as top priority with timely and consistent follow-up
• Meet and/or exceed sales forecast, goals, and objectives
• Analyze, develop, and execute territory business plan with ongoing updates based on current insights
• Compliantly guide HCPs through prescribing process and support services
• Collaborate with and provide insights to marketing, sales leadership, other key internal partner, and sales training on local market needs around disease awareness, diagnosis, treatment education, tools, and product messaging
• Execute marketing initiatives to drive success in the local geography including speaker programs
• Support HCP conferences with a presence to communicate key messages and share approved resources
• Consistently adhere to compliance guidelines
• Successfully complete all trainings in a timely manner
• Understand, acknowledge, and comply with all Chiesi Standard Operating Procedures (SOPs)
• Timely submit call activity information into the CRM (Veeva)
• Regularly complete expense reports (Concur)
• May require up to 60% travel throughout territory geography as well as to regional conferences, national sales meetings, etc. Overnight is required and on occasion weekend travel for specific conferences.

Key Account Manager, Global Rare Diseases

Medical Science Liaison

• Build external partnerships with recognized community and academic medical center KOLs to identify and address scientific needs and to stay abreast of current scientific trends in assigned Therapeutic Area.
• Cultivate existing and identify new collaborative KOL relationships for advisory boards, company-sponsored, investigator-initiated research, and speaker development
• Represent Chiesi Global Rare Diseases Medical Affairs at national, regional, and local scientific meetings
• Deliver high-caliber medical education presentations in a variety of settings
• Participate in internal therapeutic advisory groups

Medical Science Liaison, Global Rare Diseases

Controller

• Serve as the Finance Business Partner for the Core Markets Business Unit
• Support management in strategic decision-making
• Ensure robust financial governance across the area
• Work closely with management and commercial partners
• Provide financial analysis and support planning and forecasting processes
• Monitor business performance and deliver actionable insights
• Support month-end and year-end close process
• Develop and prepare accurate financial reporting package
• Coordinate financial planning, budget, and forecasting
• Review monthly results by product and geography/partner
• Cooperate with global functions and local departments
• Grow into the business partnering role providing financial views for business cases, new contracts, pricing decisions or product launches
• Assist with assessment of local processes and improvement initiatives

Financial Controller

Administrative Assistant

• Provide high-level administrative, organizational and operational support to the Senior Vice President, Manufacturing & Engineering and the Global Engineering Leadership Team.
• Manage the calendar of the Senior Vice President, Manufacturing & Engineering.
• Coordinate internal and external meetings, workshops, leadership events and business reviews.
• Prepare agendas, presentations, meeting materials and pre-read documentation.
• Track actions and follow-up activities arising from leadership meetings.
• Support governance activities and facilitate communication across internal and external stakeholders.
• Organize business travel, accommodation and related logistics.
• Manage travel expense reports and related documentation.
• Create and manage Purchase Requisitions (PR) within SAP and coordinate involved activities.

Executive Assistant, Office Manager – Temporary

General Counsel

• Legal support to all Staff functions, including both corporate Staff functions and Staff functions with global responsibilities
• Legal business partner, supporting complex, cross-functional and high‑impact projects
• Support to Finance and Global Procurement
• Involvement in sustainability projects of high strategic relevance
• Legal advice and support on staff-related matters and projects
• Legal support across the Global R&D
• Additional end-to-end legal support for all matters concerning the Paolo Chiesi Foundation

Global R&D Legal Counsel

Operations

• Deliver timely and accurate responses to enquiries across MI channels, ensuring a consistent, high-quality customer experience across all interactions.
• Tailor responses to customer needs using approved resources while maintaining scientific integrity and compliance.
• Develop clear, balanced, evidence-based MI responses for medical review and approval.
• Identify and report adverse events and product complaints in accordance with company procedures.
• Accurately document enquiries, responses and activities in MI systems to support data integrity and audit readiness.
• Collaborate with Medical Affairs, Marketing, cross-functional, and global MI teams to ensure smooth execution of MI services, activities, and delivery of initiatives.
• Contribute to MI insights reporting to inform decision-making, including analysing MI enquiry trends to identify emerging insights, unmet needs, and opportunities to enhance QUM and contribute to strategy.
• Contribute to MI content planning and product launch readiness, including content preparation and systems maintenance.
• Support responsible adoption and use of digital/AI-enabled, automation, and optimisation solutions in line with governance.
• Support Medical Affairs activities as required, including internal training, and promotional/medical education material review.
• Maintain audit and inspection readiness across all responsibilities, including support during audits as required.
• Deliver or assist with additional activities or projects as assigned by manager.

Medical Information, Operations Associate

Compliance

• May serve as a regional/local regulatory lead and point of contact both internally and with competent national authorities in EU countries and EMA.
• Contribute (independently or with GRL/ Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members
• Accountable for developing, singly or with GRL guidance/Manager support, the HA engagement & interaction plans for assigned products incl. authoring, leading & moderating preparation meetings
• Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for the projects/products in their remit
• Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations/Renewals filings meet the project timelines
• Collaborate with Project Manager to develop core global dossier and collaborate with other GRT members as appropriate
• Ensure regulatory submission timelines are aligned with program level and company objectives
• Contribute to content and reviews for regulated documents
• Support operational and compliance activities for assigned deliverables
• Support GMP, GCP, and GPV inspections from health authorities
• Accountable to provide updates on project and submissions status to GRT members
• Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners

Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety

Brand Manager

• Definir la visión, la estrategia y el plan de acción para los productos
• Adaptar las estrategias globales al mercado local
• Realizar análisis de mercado, identificar oportunidades de crecimiento y gestionar el presupuesto de marketing
• Monitorear la estrategia y las actividades de los competidores
• Liderar equipos multidisciplinarios (Marketing, Médico, Ventas, Regulación, Finanzas, etc.)
• Construir relaciones de confianza con Líderes de Opinión Clave y partes interesadas de Farmacia Hospitalaria, posicionando a Chiesi como líder en Enfermedades Raras

Brand Manager – Rare Diseases

• Create awareness around rare disease states and company marketed product(s) of focus, including proactive patient finding initiatives, lead generation and follow-up, and disease education within Lysosomal Storage Disorders (LSDs)
• Develop and execute territory strategies to identify undiagnosed or misdiagnosed patients through targeted account profiling, interpretation of diagnostic pathways, collaboration with centers of excellence, genetic counselors, infusion centers, and specialty pharmacies
• Deliver compliant disease state education to healthcare professionals and office staff regarding signs, symptoms, diagnostic challenges, and treatment considerations associated with Lysosomal Storage Disorders while ensuring timely follow-up on patient leads and referral opportunities
• Business development and prospecting
• Strategic account management – ability to translate strategy into action
• Target, plan and work consistently through all states and regions of the geography
• Manage leads as top priority with timely and consistent follow-up
• Meet and/or exceed sales forecast, goals, and objectives
• Analyze, develop, and execute territory business plan with ongoing updates based on current insights
• Compliantly guide HCPs through prescribing process and support services
• Collaborate with and provide insights to marketing, sales leadership, other key internal partners, and sales training on local market needs around disease awareness, diagnosis, treatment education, tools, and product messaging
• Execute marketing initiatives to drive success in the local geography including speaker programs
• Support HCP conferences with a presence to communicate key messages and share approved resources
• Consistently adhere to compliance guidelines
• Successfully complete all trainings in a timely manner
• Understand, acknowledge, and comply with all Chiesi Standard Operating Procedures (SOPs)
• Timely submit call activity information into the CRM (Veeva)
• Regularly complete expense reports (Concur)

Key Account Manager – Global Rare Diseases

• Maintain or create CMC regulatory documents for product submissions
• Manage CMC regulatory documents in collaboration with the Core team
• Advise project teams on regulatory agency requirements
• Review change control requests pertaining to CMC aspects
• Agree on regulatory strategy for GRD products' life cycle
• Maintain submission information and track commitments
• Work with external CMOs and cross-functional teams
• Support development of processes and Standard Operating Procedures
• Represent GRDRA during GMP inspections
• Keep abreast of current regulatory CMC requirements

Manager, CMC Regulatory Affairs – Global Rare Diseases

Director

• Owns and drives the API industrialization strategy in alignment with commercial priorities and portfolio plans.
• Ensures predictable time-to-market, reliable supply for new and existing APIs.
• Provides senior leadership input into new opportunity evaluation collaborating in due diligence processes.
• Accountable for the Life Cycle Management (LCM) strategy of the API portfolio, including robustness, capacity evolution, cost optimization, and second sourcing.
• Proactively identifies and mitigates supply, obsolescence, and margin-erosion risks over the product life cycle.
• Sponsors and contributes to continuous improvement initiatives to sustain competitiveness and long-term value.
• Supports the evaluation of manufacturing process changes and deviations, control strategy definition.
• Serves as senior technical and industrial partner to Procurement, R&D, Quality and Supply chain functions.
• Influences portfolio, investment, and prioritization decisions through strong industrial and market insight.
• Ensures API industrialization and life-cycle activities comply with GMP, regulatory requirements, and customer agreements.
• Anticipates and manages industrial and supply-chain risks with an enterprise-level perspective.
• Acts as senior technical contributor during audits.
• Assesses, reduces, mitigates supply-chain and life-cycle risks through proactive industrial leadership.

Senior Director, API Industrial Manufacturing & LCM

Scientist

• Providing hands-on scientific and technical leadership in process insourcing, technology transfer, scale-up, and validation activities
• Coordinating upstream process development, optimization, and industrialization activities with internal R&D teams and external CMOs
• Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability
• Assessing and interpreting complex scientific data to support decision-making, risk mitigation, resource allocation, and program strategy
• Applying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans
• Supporting regulatory submissions (MAA, NDA, BLA, JNDA)
• Designing, executing, and evaluating pilot-scale studies to support process development, optimization, scale-up, and technology transfer activities
• Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation
• Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports
• Delivering theoretical and practical training to Manufacturing personnel