Chiesi Group

Role Description The Patient Safety Science Lead provides safety-scientific expertise to the conduct of safety science activities and safety-related clinical development contributions for assigned development and marketed product(s). This role requires scientific leadership to ensure that the safety profiles of the concerned products are proactively monitored and assessed, using all available data sources. The Patient Safety Science Lead is responsible for managing safety surveillance and risk management activities for assigned product(s) and ensuring proactive, science-driven safety evaluation based on predictive safety strategies, robust surveillance, and informed benefit–risk decisions, soliciting medical expertise where required. You will be responsible for: - Providing safety-scientific expertise to develop a Safety Science strategy and conducting safety surveillance and risk management activities for assigned development and marketed product(s), aligned with regulatory expectations and corporate priorities. - Working in a fully integrated cross-functional context and delivering to the highest scientific and compliance standards. - Ensuring continuous access to all relevant safety data to support the integrated oversight of emerging safety profiles across the assigned product(s). - Contributing to the evaluation of safety issues using all relevant data sources. - Collaborating with stakeholders from Clinical Development, Medical Affairs, Regulatory Affairs, Quality, and other functions in the context of the Benefit Risk Team. - Working with clinical teams to implement safety input into clinical development plans, protocols, study documents, and regulatory submissions. - Developing Health Hazard Assessments for quality complaints and manufacturing deviations, in line with the GMP quality process. - Participating in the development of safety surveillance and risk management plans and other outputs for assigned product(s) as per relevant procedures, maintaining the respective documentation and logs. - Making Safety Science contributions to due diligence, partnerships, licensing opportunities, and acquisition assessments. - Supporting partner engagements for continuous information exchange, as per the PV agreement. - Participating in the implementation of improvement initiatives to increase efficiency, quality, and scientific value within Safety Science activities. - Collaborating with external providers managing outsourced activities for Patient Safety Science to ensure the communication flow for required data and the receipt and documentation of deliverables. - Collaborating with Safety Operations on a day-to-day basis to have awareness of the flow of cases, the coding, and case quality. - Contributing to the development of safety communications material for global Health Authorities and external stakeholders. - Participating as subject matter expert during inspections, audits, and regulatory interactions, participating in remediation activities as required. - Participating in scientific development opportunities to strengthen expertise in safety assessment and methodology. - Participating in innovation and best practices in safety science to strengthen Chiesi’s development and lifecycle management capabilities for the assigned products. - Supporting engagement with external stakeholders, academic groups, and service providers to enhance scientific credibility and innovation. - Contributing to the integration of emerging science, regulatory trends, and best practices into Safety Science for the concerned product(s). Qualifications - Advanced degree in Life Science, Pharmacy, Medicine or a related scientific discipline. A PhD in a topic relevant to the position is preferred. - Minimum of 8 years of general experience in patient safety and a minimum of 6 years of experience in safety science within a pharmaceutical or CRO organization, with experience in post-marketing and clinical development safety. - Proven leadership of global teams and complex safety portfolios across early and late development and post-approval products. - Expertise in global PV regulations, inspections, governance, and cross-functional collaboration. - Experience across multiple product modalities (small molecules, biologics, drug/device combination products) and therapeutic areas. - Strategic and enterprise mindset with the ability to translate safety science into decision-ready strategic insights. - Strong, balanced judgment with the confidence to lead through complexity and risk. - Proven ability to influence senior stakeholders and operate effectively in matrix environments. - Crisis leadership capability, including issue escalation and resolution. - Confident leader of a diverse team, with the ability to mentor and develop talent. - Exceptional communication, relationship-building, and collaboration skills, with the ability to integrate different viewpoints in the final decision. - Competence in working across organizational and company boundaries. - Superb planning, organizational and analytical skills, with a detail- and result-oriented approach. - High ethical standards and an unwavering commitment to patient safety and quality. Location Europe (flexible) – remote or hybrid Compensation range The minimum salary for this role is €68.500, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications, and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including company car, pension, private medical insurance, wellbeing programme, flexible benefits programme and more. The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. - Top-class benefits, including comprehensive healthcare programs. - Work-life balance initiatives. - Robust relocation support. - Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. - Flexible working arrangements and remote work options. - Tax assistance services for foreign colleagues. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

Role Description This is what you will do: - Reporting to the VP, RWE, the Real World Evidence Lead Endocrine-Metabolic (Endo-Met) is responsible for leading and executing the global RWE strategy and vision for the Endo-Met Portfolio within GRD. - The role ensures the strategy, creation and updating of the integrated evidence generation plan (IEGP), in alignment with cross-functional partners to meet research and commercial objectives. - The role drives enterprise-level RWE impact, including building strategic data partnerships, advancing innovative methodologies, and influencing cross-functional decision-making. You will be responsible for: - RWE Strategy & Leadership: - Act as a change agent, effectively communicating the value of RWE and influencing adoption of new processes and approaches. - Lead the global RWE strategy for the Endo-Met GRD portfolio, ensuring integration into regulatory, payer, and clinical decision-making. - Increase the integration of RWD sources to enhance evidence-based decision making through research programs. - Publish, where appropriate, in high impact journals. - Capability Building & Organizational Leadership: - Continuously improve RWE capabilities, processes, and infrastructure to support global and local evidence generation. - Build and scale RWE capabilities as a competitive advantage for GRD. - Establish best practices, standards, and ways of working across regions. - Lead change management to embed RWE into core organizational processes. - External Data & Partnership Strategy: - Lead identification, evaluation, and execution of external RWD partnerships and data acquisition strategies. - Oversee due diligence, contracting support, and governance of external data sources and collaborations. - Build long-term strategic relationships with academic institutions, data vendors, consortia, and healthcare systems. - Scientific & Technical Leadership: - Foster the appropriate use and adoption of analytic technologies to improve RWE reliability and applicability. - Provide senior scientific leadership and deep technical expertise in observational research, epidemiology, and RWE methodologies. - Guide study design, analytics strategy, and interpretation of evidence. - Ensure adoption of innovative approaches, including AI/ML and advanced analytics, in RWE generation. - Cross-Functional Influence & Integration: - Act as the RWE subject matter expert within cross-functional teams. - Influence asset strategies, development plans, and access strategies. - Lead alignment of RWE priorities across global and regional stakeholders. - Evidence Generation Oversight: - Provide executive oversight of RWE studies, registries, and non-interventional programs. - Maintain governance of study concept development and prioritization. - External Scientific Leadership & Visibility: - Represent Chiesi externally in scientific forums, consortia, and partnerships. - Drive publication strategy and dissemination of RWE insights. - Maintain awareness of emerging trends, regulatory guidance, and methodological advances. - Leadership & Matrix Management: - Lead cross-functional and multidisciplinary teams in a matrix environment. - Oversee budgets, timelines, and resource allocation across RWE initiatives. - Manage consultants, mentor junior team members, and direct reports over time. Qualifications - Advanced degree (PhD, DrPH, MD, PharmD, MSc) in epidemiology, public health, health economics, or related field. - 8+ years of experience in RWE, HEOR, epidemiology, or observational research in pharma/biotech or related setting. - Demonstrated success in leading RWE strategy at asset or portfolio level. - Strong experience in real-world data sources (claims, EHR, registries, etc.). - Proven track record of building partnerships and influencing senior stakeholders. - Experience supporting regulatory and/or market access use of RWE. - Deep expertise in epidemiology and RWE methodologies. - Ability to translate evidence into business and clinical impact. - Demonstrated ability to influence senior stakeholders and cross-functional leadership. - Strong executive communication skills. - Experience with advanced analytics, AI/ML, and innovative RWE approaches. - Ability to shape data strategy and infrastructure decisions. - Strong governance and oversight of complex, multi-country studies and programs. - Ability to manage competing priorities and large-scale initiatives. Requirements - Rare disease experience strongly preferred. Benefits - The minimum salary for this role is €81.121, aligned to our established salary framework. - This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. - Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. - Location: The role can be based in one of our affiliates in Europe, with an estimated 20% of travel requirement, including international travel.

Role Description This is what you will do: - Reporting to the VP, RWE, the Real World Evidence Lead Endocrine-Metabolic (Endo-Met) is responsible for leading and executing the global RWE strategy and vision for the Endo-Met Portfolio within GRD. - The role ensures the strategy, creation and updating of the integrated evidence generation plan (IEGP), in alignment with cross-functional partners to meet research and commercial objectives. - The role drives enterprise-level RWE impact, including building strategic data partnerships, advancing innovative methodologies, and influencing cross-functional decision-making. You will be responsible for: - RWE Strategy & Leadership: - Act as a change agent, effectively communicating the value of RWE and influencing adoption of new processes and approaches. - Lead the global RWE strategy for the Endo-Met GRD portfolio, acting as the strategic RWE leader across development, regulatory, and commercialization phases. - Ensure integration into regulatory, payer, and clinical decision-making across the Endo-Metabolic Portfolio including Myalepta® (metreleptin) in Lipodystrophy, Juxtapid® / Lojuxta® (lomitapide) in Homozygous Familial Hypercholesterolemia (HoFH) and future pipeline or acquired assets. - Increase the integration of RWD sources to enhance evidence-based decision making through research programs. - Publish, where appropriate in high impact journals. - Capability Building & Organizational Leadership: - Continuously improve RWE capabilities, processes, and infrastructure to support global and local evidence generation for HIDO. - Build and scale RWE capabilities as a competitive advantage for GRD. - Establish best practices, standards, and ways of working across regions. - Lead change management to embed RWE into core organizational processes. - External Data & Partnership Strategy: - Lead identification, evaluation, and execution of external RWD partnerships and data acquisition strategies. - Oversee due diligence, contracting support, and governance of external data sources and collaborations. - Build long-term strategic relationships with academic institutions, data vendors, consortia, and healthcare systems. - Scientific & Technical Leadership: - Foster the appropriate use and adoption of appropriate analytic technologies to improve RWE reliability and applicability. - Provide senior scientific leadership and deep technical expertise in observational research, epidemiology, and RWE methodologies. - Guide study design, analytics strategy, and interpretation of evidence. - Ensure adoption of innovative approaches, including AI/ML and advanced analytics, in RWE generation. - Cross-Functional Influence & Integration: - Act as the RWE subject matter expert within cross-functional teams (Medical, Clinical Development, Market Access, Regulatory). - Influence asset strategies, development plans, and access strategies. - Lead alignment of RWE priorities across global and regional stakeholders. - Evidence Generation Oversight: - Provide executive oversight of RWE studies, registries, and non-interventional programs. - Ensure studies are aligned to strategic priorities and deliver high-impact outcomes. - Maintain governance of study concept development and prioritization. - External Scientific Leadership & Visibility: - Represent Chiesi externally in scientific forums, consortia, and partnerships. - Drive publication strategy and dissemination of RWE insights. - Maintain awareness of emerging trends, regulatory guidance, and methodological advances. - Leadership & Matrix Management: - Lead cross-functional and multidisciplinary teams in a matrix environment. - Oversee budgets, timelines, and resource allocation across RWE initiatives. - Manage consultants, mentor junior team members and as needed, direct reports over time. Qualifications - Advanced degree (PhD, DrPH, MD, PharmD, MSc) in epidemiology, public health, health economics, or related field. - 8+ years of experience in RWE, HEOR, epidemiology, or observational research in pharma/biotech or related setting. - Demonstrated success in leading RWE strategy at asset or portfolio level. - Strong experience in real-world data sources (claims, EHR, registries, etc.). - Proven track record of building partnerships and influencing senior stakeholders. - Experience supporting regulatory and/or market access use of RWE. - Deep expertise in epidemiology and RWE methodologies. - Ability to translate evidence into business and clinical impact. - Demonstrated ability to influence senior stakeholders and cross-functional leadership. - Strong executive communication skills. - Experience with advanced analytics, AI/ML, and innovative RWE approaches. - Ability to shape data strategy and infrastructure decisions. - Strong governance and oversight of complex, multi-country studies and programs. - Ability to manage competing priorities and large-scale initiatives. Requirements - Rare disease experience strongly preferred. Benefits - The minimum salary for this role is €81.121, aligned to our established salary framework. - This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. - Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. Location - The role can be based in one of our affiliates in Europe, with an estimated 20% of travel requirement, including international travel. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. - Top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. - Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. - Flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.

Role Description The MSL Manager is responsible for leading and managing a team of Medical Science Liaisons (MSLs) to support the company's strategic objectives in the LSD (Lysosomal Storage Disorders) Therapeutic Area. This role involves strategic planning, team management, and ensuring the effective communication of scientific information to healthcare professionals. The MSL Manager will work closely with cross-functional teams to drive medical strategies and enhance stakeholder relationships and support the Head of Medical Affairs Field Team in ensuring field medical strategy and tactics are successfully employed and benchmarked. - Lead, mentor, and manage a team of LSD MSLs, providing guidance and support to ensure high performance. - Conduct regular performance evaluations, set objectives, and implement development plans for team members. - Oversee recruitment, training, and onboarding of new MSLs. - Develop and implement strategic plans to ensure the MSL team meets GRD and company goals and objectives. - Collaborate with senior management to align MSL activities with broader medical and commercial strategies. - Foster and maintain relationships with key opinion leaders (KOLs) and other stakeholders in the medical community. - Ensure MSLs effectively communicate scientific and clinical information to external stakeholders. - Monitor and analyze MSL activities to ensure compliance with company policies, regulatory requirements, and industry standards. - Review and approve MSL reports, presentations, and other materials to ensure accuracy and relevance. - Work closely with other departments, including Clinical Development, Regulatory Affairs, and Commercial teams, to support integrated medical strategies. - Provide insights and feedback to internal teams based on interactions with healthcare professionals and KOLs. - Analyze data from MSL interactions and provide strategic recommendations based on insights gathered. - Prepare and present regular reports on team performance, key activities, and impact on strategic objectives. - Ensure that all MSL activities are conducted in compliance with ethical guidelines, industry regulations, and company policies. - Address and resolve any compliance issues promptly. Qualifications - Graduate level degree (PharmD., M.D., D.O, PhD, MS or equivalent). - Experience in pharmaceutical industry as an MSL for at least 5 years. - Leadership or management experience within field medical affairs for 1-2 years. - Knowledge and experience in interpreting and adhering to FDA regulations regarding product promotion, scientific exchange, and health care practitioner guidelines. - Demonstrated proficiency in written, verbal, and face-to-face communications to effectively present information to and influence/support decision-making of KOLs, direct MSL reports, medical affairs leadership, and cross-functional partners. - Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to changing priorities. - Proficient in MS Office (Word, Excel, PowerPoint, Teams), Adobe, etc. Requirements - Prior experience in Rare disease. Location - Field-Based/Remote position, up to 75% travel as necessary to meet job requirements. Compensation The annual base pay for this position ranges from $163,000 to $245,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Benefits - Comprehensive healthcare programs. - Work-life balance initiatives. - Robust relocation support. - Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. - Flexible working arrangements and remote work options. - Tax assistance services for foreign colleagues. Company Description Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Role Description This is what you will do: - Responsible for maintenance of North American labelling processes ensuring compliance with applicable Health Authorities regulations and guidelines, internal company procedures and business objectives. - Responsible for the regulatory review of advertising and promotional materials for products approved in the US market and other markets as applicable. - This position is also responsible for providing input to risk management activities. You’ll be responsible for: Labelling Responsibilities: - Manage activities related to the development, revision, and maintenance of product labelling including the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labelling and product artwork, Summary of Product Characteristics (SmPC), Product Monographs (PM) and related documents. - Strategically engage in product development and lifecycle management aligned to the global labelling and promotional strategy. - Support the GRDRA Therapeutic Areas cross-functional teams through labelling discussions with Health Authorities while ensuring management alignment. - Support the GRDRA Therapeutic Areas to ensure submission of labelling materials and supporting documentation to health authorities (FDA form 2253 submissions). - Support regulatory decisions related to Clinical and Global Development programs in accordance with health authority’s requirements. Promotional Labelling/External Communications Responsibilities: - Manage regulatory advertising and promotion efforts to ensure that activities and communications are consistent with product labelling and in compliance with relevant Health Authorities’ applicable laws, regulations and policies related to advertising & promotion of prescription products. - Lead the regulatory review of promotional materials related to marketed products disease state information and external communications. - Oversee the submission of advertising and promotional materials to Health Authorities in accordance with submission requirements. Additional Responsibilities: - Participate in risk management activities for promotional materials within Chiesi and work with other departments to ensure the regulatory perspective is appropriately communicated. - Update/review Standard Operating Procedures and internal guidance documents for related activities and provide training to Regulatory Affairs and other departments and/or affiliates as appropriate. - Interact with senior management, external departments and health authorities as needed in the activities of the Global Regulatory Affairs group. - Support audits/inspections as a global labelling lead. - Regulatory oversight of electronic systems (for example, Veeva PromoMats validation and updates). Qualifications - Bachelor’s Degree in Life Sciences or related field. - 5 years of relevant experience related to regulatory labelling and promotional experience. - Experience managing complex multifunctional teams including regulatory colleagues. - Knowledge regarding global and US labelling requirements, including US Advertising and Promotional requirements. - Knowledge of regulatory strategy and clinical studies. - Excellent knowledge of pharmaceutical development. - Prior experience in preparation of labelling documents for new drug/biologic/device applications. - Experience with reviewing advertising materials for product launch. - Project management skills with the ability to handle multiple projects and prioritize work accordingly. - Experience communicating with regulatory authorities on issues related to labelling and advertising. Experience in preparing for and participating in regulatory health authority meetings preferred. - Target Product Labelling experience. Requirements - Post-graduate degree in life sciences or related field preferred. - RAC or Post-Graduate Master Certification Recommended. Benefits - Comprehensive healthcare programs. - Work-life balance initiatives. - Robust relocation support. - Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. - Flexible working arrangements and remote work options. - Tax assistance services for foreign colleagues.

Role Description We are seeking a Key Account Manager (KAM) who is a competitive, pharmaceutical sales professional with integrity, drive and passion for performance who can thrive in a fast-paced business environment. This individual must have experience with strategic account management, identifying opportunities through local market intelligence gathering and effective data analysis. The KAM will act as the face of our great company to healthcare professionals, including prescribers and their staff, while focusing on meeting and exceeding their sales goals to ensure appropriate patients get prescribed our medication. The Key Account Manager (KAM) will deliver product, disease state and resource education to HCPs & their staff to expand their identification and treatment of appropriate patients with our medication. The KAM will report directly to the National Business Director while working with peer salespeople as well as a cross-functional team to ensure the marketplace understands clinical data, payer access information and company resources to support prescribing, initiation, and continuity of therapy for patients. The KAM role requires a unique set of skills that demands excellent customer engagement & communication skills, strategic planning & execution, clinical expertise, collaboration, consistent compliant behaviors, and a commitment to the patients and their families. This person must enjoy working within a high functioning team with the goal to help everyone succeed for the benefit of the patients we serve. - 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. Qualifications - Bachelor’s Degree from an accredited four-year institution (education in science or business a plus) - 10+ years pharma industry experience in related, diverse function/roles - Clinical experience selling specialty/rare disease products in a large geography consisting of multiple states - Expansive local relationships, access, and market knowledge - Proven track record of delivering top sales performance that meet or exceed targeted objectives - Excellent virtual/remote selling and customer engagement skills along with verbal and written communication skills - Expansive account management skills - Proven effective collaboration skills - Demonstrated highest ethical standards - Rare disease or biologics selling experience - Proven strategic problem-solving ability - Demonstrated competency working across teams and sharing information proactively - Experience with Veeva, SalesForce.com, Microsoft Office (i.e., Outlook, Excel, etc.), Concur, Zoom, TEAMs, WebEx - Thorough knowledge of healthcare regulations, compliance standards, and hospital credentialing processes. This includes obtaining and maintaining the necessary hospital credentials to access and operate within healthcare institutions. Credentialing includes successful completion of a drug test, including testing for marijuana. Location Field-Based/Remote position, up to 60% travel as necessary to meet job requirements; Candidates should live in/near the following territory locations: ME, NH, MA, CT, VT, RI, or NY. No relocation support will be offered for position. Compensation The annual base pay for this position ranges from $161,280 to $197,120. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Benefits - Comprehensive healthcare programs - Work-life balance initiatives - Robust relocation support - Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market - Flexible working arrangements - Remote work options - Tax assistance services for foreign colleagues

Role Description Provide high-level administrative, organizational and operational support to the Senior Vice President, Manufacturing & Engineering and the Global Engineering Leadership Team. The role is responsible for ensuring efficient day-to-day operations, supporting governance activities, coordinating administrative processes, monitoring cost centers and headcount data, and facilitating communication across internal and external stakeholders. You will be responsible for - Executive Support - Manage the calendar of the Senior Vice President, Manufacturing & Engineering, ensuring effective prioritization of meetings and activities. - 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 the Senior Vice President and Leadership Team in managing communications and organizational activities. - Office Management & Administration - Organize business travel, accommodation and related logistics. - Manage travel expense reports and related documentation. - Support document management and filing activities. - Coordinate team meetings, workshops and events. - SAP & Procurement Support - Create and manage Purchase Requisitions (PR) within SAP. - Coordinate Service Entry Sheets (SES), purchase orders and invoice-related activities. - Liaise with Procurement, Finance and suppliers to ensure timely processing of requests. - Monitor open purchase requests and ensure proper follow-up. - Support contract and supplier administration activities when required. - Budget & Cost Control Support - Support monitoring and reporting of the Global Manufacturing & Engineering Opex budget. - Maintain and update budget tracking files and cost center reports. - Prepare regular reports and analyses to support management decision-making. - Monitor expenditures and identify variances against budget. - Coordinate with Industrial Controlling and Finance on cost center-related activities. - Governance & Cross-Functional Coordination - Support governance processes within Global Manufacturing & Engineering. - Ensure proper coordination between Global Manufacturing & Engineering and TechOp&S governance routines. - Support transversal projects and initiatives across different functions and sites. - Ensure timely collection, consolidation and distribution of information required by leadership. - Reporting & Data Analysis - Prepare reports, dashboards and presentations using Excel and PowerPoint. - Analyze and consolidate data from different sources. - Maintain tracking tools and databases. - Support management reporting activities and preparation of executive presentations. Qualifications - At least 6 months of experience in Executive Assistant, Office Manager, Administrative Coordinator or similar roles. - Fluent Italian and English. - Ability to manage multiple priorities in a dynamic international environment. - Strong organizational skills. - Stakeholder Management & Communication. - Problem Solving, Proactivity & Attention to Detail. - Confidentiality, Professionalism & Independent Working. Requirements - Knowledge of SAP. - Knowledge of Excel and PowerPoint. - Proven experience supporting senior leaders in an international environment. - Experience managing complex calendars, meetings and business priorities. - Experience with procurement and administrative processes. - Experience in cost centers tracking and reporting activities. Benefits - Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. - Top-class benefits including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. - Competitive salary package comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. - Flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.

• 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

Role Description This is what you will do: - Functions as a Lead Statistical Programmer, participates in SAS related programming activities for all clinical and safety data systems at Chiesi as well as activities in preparing data and metadata packages for regulatory submission. - The Principal Statistical Programmer is responsible for project-specific internal and external deliverables regarding SAS programming to be completed within budget and on time. You will be responsible for: - Establishes the SAS programming needs for a project and develops work-plan to deliver SAS outputs to meet project deliverables. - Responsible for the production of quality data outputs and preserving data integrity. - Participates in the writing, validation and maintenance of SAS programs to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trial, safety and post marketing data residing in all data systems owned by Chiesi GRD. - Builds and maintains a library of SAS programs and develops surrounding processes. - Performs and documents validation (quality control checks) of various outputs and programs to support Chiesi’s deliverables. - Supports in providing expertise regarding data collection, set up and the impact on the data and metadata packages. Provides feedback to ensure the data is collected in a standardized manner and annotated as per standards required for submission. - Contributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs. - Builds a library of standard edit checks in SAS to supplement edit checks in data systems owned by DM, Chiesi or in datasets received via CROs, looking for trends that could indicate problems with protocol adherence or data issues. - Develops Case Report Tabulations (datasets, transport files) and associated metadata documentation for submissions using advanced knowledge of CDISC standards. Creates/adjusts processes as needed to ensure compliance with data submission standards. - Provides technical expertise as needed for all programming issues. - Participates in defining new SAS programming requirements for new, complex projects based on protocol and disease under study. - Utilizes advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting. - Demonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level (e.g. issues that arise from discrepancy management process). - Demonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project. - Shows initiative in keeping self at the “leading-edge” of their field. - Performs all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines. Maintains and further develops and in-depth knowledge of these documents. - Participates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs. - Works as a member of a team to achieve all outcomes. - Performs all work in accordance with all established regulatory and compliance and safety requirements. - Fulfil a leading role in set-up and maintenance of data warehouse activities. - Initiate and develop novel tools to support the decision making process. - Leads any submission related programming activities. - Oversees any programming activities as performed by a CRO. Qualifications - Bachelor’s Degree in a related field required (e.g. Health Sciences, Statistics, Computer Science). Master’s preferred. - More than 7 years of Pharmaceutical/CRO experience. - High level of SAS experience and expertise as demonstrated in previous work. - A solid understanding of the Data Management and Biostatistics processes. - Experience cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset. - Experience in creating and maintaining a SAS reporting system to generate listings, tables and flexible data outputs. - In-depth understanding of CDISC standards. - Demonstrates effective organizational and time-management skills. - Ability to manage multiple priorities in an efficient manner. - Demonstrates ability to work independently and as part of a team. - SAS certification and/or A. Stat or P. Stat accreditation are definite assets. - English fluent. Requirements - Location: Europe (flexible) – remote or hybrid. Benefits - The minimum salary for this role is €46,000, aligned to our established salary framework. - This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. - Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.

• 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)