33 English-speaking jobs in Parma

Ensure pharmacovigilance quality system compliance with regulations and standards. Manage deviations, monitor CAPAs, and review SOP/WIs. Requires Life Sciences degree and 3-5 years in pharmacovigilance/QA.

Senior Technical Leader in GRD CMC with end-to-end responsibility for CMC strategy, execution, and risk management. Expertise includes analytical method development, validation, and control strategy for biological products.

The Global New Product Planning Manager will complete strategic commercial assessments to drive early pipeline development and due diligence. Responsibilities include assessing market landscapes, revenue forecasts, and developing investment stories. A medical or scientific background is preferred.

Manage GCP compliance, CAPAs, and quality metrics within Global R&D. Execute first and second-party audits and finalize quality documents. Requires 3+ years in Pharma/CRO QA with strong GCP knowledge.

Drive global supplier quality oversight and lifecycle management for APIs, packaging, and critical GxP suppliers. Define strategy, governance, and performance monitoring across the supply chain.

Support Chiesi's Global Workplace and Real Estate strategy across affiliates. This role manages workplace standards, office transformations, and real estate portfolio evaluations. Requires a Master's degree and 3-6 years of relevant experience.

Manage the Pharmacovigilance System Master File (PSMF) and ensure compliance with regulatory requirements. Evaluate guidelines, update PSMF documentation, define KPIs, and report on PV system performance. Requires a Master's degree and 5+ years in international Pharmacovigilance.

Senior Technical Leader for GRD CMC is accountable for CMC development and IMP supply strategy from nomination to commercial launch. Requires 10+ years in pharma, experience with regulatory interactions (EMA/FDA), and leadership of internal/external teams.

Senior Technical Leader for Protein Biologics Development in GRD CMC. Lead CMC strategies for recombinant protein therapeutics, covering expression, upstream/downstream process development, and quality attributes.

Principal Statistician for Global Rare Diseases. Provide statistical expertise for drug development programs, clinical trials, and regulatory submissions. Requires PhD/MSc in Statistics and 10+ years in clinical trials.

Define and execute the global publication strategy and tactical plan for all global studies. Ensure timely, compliant dissemination of scientific data via congress presentations and peer-reviewed publications.

Senior Manager, CMC Regulatory Affairs, Global Rare Diseases. Requires 7+ years of Regulatory CMC experience, 3+ in Biologics/Biopharmaceuticals, and advanced knowledge of global CMC regulations.

Manage training and documentation across Global TechOps & Supply. Oversee EDMS, training systems, and document control, ensuring regulatory compliance. Requires 5+ years in pharma QA with scientific degree.

Provide legal support to Staff and Global R&D functions, including contract drafting, negotiation, and risk evaluation. Responsibilities cover finance, procurement, sustainability, and clinical/preclinical studies. Requires a Master's in law and 2-3 years of relevant experience.

Lead global post-marketing pharmacovigilance operations, ensuring data quality and compliance for Chiesi's portfolio. Oversee safety data collection, literature review, and stakeholder engagement.

Clinical Partnership Manager to optimize governance and operational models for strategic CRO partnerships. Develop and manage vendor relationships, ensuring high-quality clinical trial delivery and continuous improvement. Requires 8-10 years in Clinical Operations.

Lead Statistical Programmer responsible for SAS programming for clinical and safety data systems. Develop work plans, ensure data integrity, and support regulatory submissions using CDISC standards.

Principal Regulatory Writer for Global Rare Diseases. Author, review, and manage regulatory documents for global health authorities, translating clinical and CMC data into compliant submissions across the product lifecycle.

Senior Clinical Project Manager coordinates operational management for assigned projects to develop compounds. Responsibilities include managing clinical trials, CRO oversight, budget adherence, and ensuring compliance with SOP and GCP.

Senior Process Scientist needed for gRNA process development. Lead process development and manufacturing oversight for gene therapy programs, focusing on in vivo LNP programs. Expertise in gRNA development, synthetic nucleotide manufacturing, and CRO/CDMO management is required.