Provide statistical expertise and leadership for drug development programs, including study design, regulatory submissions, and data interpretation. Oversee statistical activities for clinical trials while collaborating with cross-functional teams and external vendors to ensure compliance with regulatory standards.
Chiesi Group
26 Remote Job Openings at Chiesi Group
The Hospital Sales Specialist is responsible for achieving quarterly and annual sales objectives by promoting Chiesi USA products to targeted hospital customers. They will conduct clinical in-services, navigate hospital formulary processes, and develop territory business plans to drive product access and adoption.
The Patient Safety Science Lead provides scientific expertise to monitor and assess the safety profiles of development and marketed products. This includes managing safety surveillance, risk management activities, and collaborating with cross-functional teams to ensure informed benefit-risk decisions.
Real World Evidence Lead, HIDO, Global Rare Diseases
Chiesi Group
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Full Time
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12 days ago
Chiesi Group
Lead and execute the global Real World Evidence (RWE) strategy for the HIDO portfolio to meet research and commercial objectives. This includes building strategic data partnerships, overseeing evidence generation plans, and influencing cross-functional decision-making across regulatory and clinical phases.
RealReal World Evidence Lead, HIDO, Global Rare Diseases
Chiesi Group
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Full Time
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12 days ago
Chiesi Group
Lead the global Real World Evidence (RWE) strategy and integrated evidence generation plans for the HIDO portfolio within Global Rare Diseases. Drive enterprise-level impact by building strategic data partnerships and influencing cross-functional decision-making across regulatory and commercial phases.
Real World Evidence Lead Endo-Metabolic, Global Rare Diseases
Chiesi Group
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Full Time
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12 days ago
Chiesi Group
Lead and execute the global Real World Evidence (RWE) strategy and integrated evidence generation plans for the Endocrine-Metabolic portfolio. Drive strategic data partnerships and provide scientific leadership to influence regulatory, payer, and clinical decision-making.
Lead and manage a team of Medical Science Liaisons to support strategic objectives within the Lysosomal Storage Disorders therapeutic area. This includes overseeing scientific communication to healthcare professionals and collaborating with cross-functional teams to drive medical strategies.
Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases
Chiesi Group
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Full Time
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14 days ago
Chiesi Group
Manage North American labeling processes and regulatory review of advertising and promotional materials to ensure compliance with Health Authority regulations. Lead the submission of labeling and promotional documents while providing regulatory oversight for electronic systems like Veeva PromoMats.
Key Account Manager, Global Rare Diseases - Northeast
Chiesi Group
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Full Time
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20 days ago
Chiesi Group
The Key Account Manager is responsible for driving sales and awareness of rare disease treatments by educating healthcare professionals and managing strategic accounts. They will develop territory business plans and collaborate with cross-functional teams to ensure patient access to medication.
Medical Science Liaison, Global Rare Diseases - Midwest
Chiesi Group
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Full Time
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20 days ago
Chiesi Group
The Medical Science Liaison (MSL) is responsible for building partnerships with key opinion leaders and engaging in scientific exchanges with external stakeholders. This includes providing medical support, delivering education, and fostering collaborations in the assigned therapeutic areas.
Lead SAS programming activities for clinical and safety data systems to prepare data and metadata packages for regulatory submissions. Responsible for producing quality data outputs, maintaining SAS libraries, and overseeing programming activities performed by CROs.
Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety - Temporary
Chiesi Group
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Part Time
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a month ago
Chiesi Group
The role involves defining and executing global regulatory strategies and serving as the primary point of contact for health authorities in the EU and EMA. Responsibilities include managing regulatory filings such as MAAs and variations while ensuring alignment with product labeling and project timelines.
Lead the analytical development and control strategy for gene editing and mRNA-LNP products from candidate selection through commercial launch. Manage outsourced activities with CROs/CDMOs and author critical technical and regulatory documentation.
Senior Process Scientist - gRNA process development
Chiesi Group
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Full Time
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a month ago
Chiesi Group
Lead the development plan, manufacturing, and controls strategy for synthetic nucleotides and gRNA-based products. Manage outsourced process development activities with CROs/CDMOs and contribute to regulatory documentation such as IND and IMPD.
R&D GRAPS Affiliate and Partnership Oversight Unit Head
Chiesi Group
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Full Time
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a month ago
Chiesi Group
Manage relationships with partners and affiliates to ensure global regulatory compliance and patient safety. Oversee the development and maintenance of Safety Data Exchange Agreements (SDEAs) and act as the primary subject matter expert during audits.
Clinical Research Physician, Global Rare Diseases
Chiesi Group
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Full Time
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a month ago
Chiesi Group
Support the medical and scientific aspects of global clinical studies for rare diseases, including acting as a medical monitor and contributing to the Common Technical Document. Collaborate with internal and external stakeholders to ensure the design, conduct, and interpretation of clinical trials align with business strategy and patient needs.
Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
Chiesi Group
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Full Time
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2 months ago
Chiesi Group
Responsible for creating and maintaining CMC regulatory documents and strategies for a global portfolio of rare disease products. This includes authoring submission sections, managing change controls, and representing the company during GMP inspections.
The Senior Global Patient Safety Physician provides medical expertise to lead safety science activities and risk management for development and marketed products. This includes monitoring safety profiles, collaborating with cross-functional teams, and ensuring compliance with global regulatory standards.
Principal Regulatory Writer, Global Rare Diseases
Chiesi Group
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Full Time
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2 months ago
Chiesi Group
The Principal Regulatory Writer authors and manages complex regulatory documents for global health authorities to support drug applications and lifecycle activities. They lead cross-functional teams to ensure scientific rigor and compliance across clinical, nonclinical, and CMC data.
Support real-world evidence research by designing and executing studies, performing data analysis on large healthcare datasets, and communicating findings. Collaborate with internal and external partners to meet regulatory, clinical, and commercial objectives.
The specialist is responsible for promoting and selling CARE hospital products within the Little Rock territory to achieve annual sales goals. This includes conducting clinical discussions with healthcare professionals and navigating the hospital formulary process.
The specialist is responsible for achieving sales objectives for hospital products by promoting them to physicians and pharmacists within the Little Rock territory. This includes navigating hospital formulary processes, conducting clinical discussions, and developing territory business plans.
The specialist is responsible for achieving sales objectives for hospital products by promoting them to physicians and pharmacists within an assigned territory. This includes navigating hospital formulary processes and developing strategic business plans to drive product adoption.
Sr. Medical Science Liaison, Global Rare Diseases - Central
Chiesi Group
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Full Time
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4 months ago
Chiesi Group
The Senior Medical Science Liaison is responsible for building partnerships with key opinion leaders and facilitating the exchange of scientific data in the Rare Dermatology space. They will also provide medical support for clinical research, deliver educational presentations, and gather field insights to inform organizational strategy.
Senior Director, Clinical Biometrics & Analytics
Chiesi Group
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Full Time
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8 months ago
Chiesi Group
The Senior Director will oversee Data Management, Biostatistics, and Statistical Programming functions, driving the vision and execution of clinical data strategies. This role includes building high-performing teams and fostering a culture of collaboration and continuous improvement.
The R&D Data Elaboration Head is responsible for leading the digital transformation of R&D through data elaboration and visualization. This role involves overseeing the lifecycle of data models, developing analytical models, and fostering a culture of innovation within the team.
