Telix Pharmaceuticals Limited

www.telixpharma.com

6 Jobs

608 Employees

About the Company

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with commercial operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of radiopharmaceutical products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Listed Jobs

Company Name: Telix Pharmaceuticals Limited
Job Title: IT SOX Compliance Auditor
Job Description: **Job Title:** IT SOX Compliance Auditor **Role Summary:** Oversees global IT SOX compliance, ensuring adherence to financial reporting regulations through testing, documentation, and improvement of IT controls. **Expactations:** 5+ years in IT SOX compliance, IT auditing, or IT risk management; must demonstrate expertise in IT controls for financial reporting. **Key Responsibilities:** - Execute global IT SOX compliance testing, including IT general controls (ITGCs), application controls, segregation of duties (SoD), and automated financial reporting controls. - Identify compliance risks aligned with COSO framework, document deficiencies, and collaborate on remediation. - Partner with IT and cross-functional teams to design, implement, and maintain IT controls over financial reporting (ICFR). - Support external auditors during SOX audits and prepare presentations for leadership on compliance status and findings. - Drive process improvements in IT SOX compliance and integrate controls for new acquisitions. **Required Skills:** - Expertise in IT SOX compliance (ITGCs, SoD, automated controls). - Strong communication and collaboration abilities to coordinate with IT, finance, and audit teams. - Risk assessment and documentation of compliance gaps. **Required Education & Certifications:** - Bachelor’s degree in Information Technology, Computer Science, Accounting, Finance, or related field. - Preferred certifications: CISA, CISSP, or CIA (not mandatory).

Company Name: Telix Pharmaceuticals Limited
Job Title: Key Account Manager (Oncology)
Job Description

Company Name: Telix Pharmaceuticals Limited
Job Title: Medical Writer
Job Description: **Job Title** Medical Writer **Role Summary** Prepare, edit, and compile regulatory and clinical documents for drug development, including CSRs, IBs, safety narratives, and eCTD summaries, for IND, NDA, MAA, and BLA submissions. Collaborate with cross‑functional teams to ensure accuracy, compliance, and timely delivery of high‑quality written materials. **Expectations** - Produce clear, precise, and regulatory‑compliant manuscripts within defined timelines. - Lead writing projects, manage document versions, and maintain style guides and SOPs. - Engage with clinicians, statisticians, and regulatory affairs to resolve queries and incorporate data. **Key Responsibilities** - Draft and edit clinical study reports, investigator brochures, safety narratives, integrated safety summaries, and eCTD clinical summaries. - Compile and summarize data from study reports, statistical analyses, and literature reviews. - Generate responses to regulatory authority questions and amend submissions as required. - Develop templates, style guides, and SOPs for consistent documentation. - Maintain up‑to‑date knowledge of drug development, regulatory frameworks (CFR, FDA, EMA, ICH), and statistical methodology. **Required Skills** - Excellent written and verbal communication in English. - Proficient with Microsoft Word, document templates, version control, and regulatory filing tools. - Strong analytical ability to interpret clinical data and literature. - Project management, organization, and attention to detail. - Ability to work independently and collaboratively across multidisciplinary teams. **Required Education & Certifications** - Bachelor of Science in a science or related field (advanced degree preferred). - Minimum 5 years of regulatory medical writing experience. - Knowledge of clinical study design, drug development, and regulatory requirements.

Company Name: Telix Pharmaceuticals Limited
Job Title: Warehouse & Purchasing Specialist
Job Description: **Job Title:** Warehouse & Purchasing Specialist **Role Summary:** Manage purchasing, receipt, storage, and inventory control of critical materials in a GMP‑compliant pharmaceutical environment. Ensure accurate master data, maintain optimal stock levels, and support laboratory and manufacturing operations through timely material preparation and compliance with SOPs, quality records, and regulatory requirements. **Expectations:** - Maintain accurate inventory values and prevent stockouts or overstock. - Ensure 100% compliance with GMP, SOPs, and quality systems for all warehouse activities. - Deliver reliable purchasing and material support to manufacturing, QC, and development teams. - Provide timely KPI reporting and data extraction for department performance monitoring. - Uphold 5S warehouse organization and continuous improvement standards. **Key Responsibilities:** - Oversee daily purchasing, reception, and storage processes. - Create and maintain item master data in SAP B1 for new GxP products, coordinating with Quality and end‑user teams. - Define item specifications (UoM, storage conditions, lead time, MOQ, reorder points) based on Master Batch Records or laboratory requests. - Conduct cycle counts and annual physical inventories; reconcile ERP records with actual stock. - Manage expired, rejected, or non‑conforming items through quality processes (periodic checks, events, deviations, CAPA). - Apply 5S methodology to ensure organized, safe warehouse operations. - Monitor, analyze, and report key performance indicators for purchasing and warehouse functions. - Support deviation, CAPA, and change control activities related to material handling. - Collaborate with cross‑functional regional and global teams; work independently as required. **Required Skills:** - Strong knowledge of GMP and pharmaceutical supply‑chain regulations. - Proficiency with ERP systems, specifically SAP Business One, and electronic QMS (e.g., MasterControl). - Inventory management, master data governance, and KPI reporting. - Experience handling deviations, CAPA, and change controls. - Excellent communication in English and French (written and spoken). - Ability to work autonomously and within multidisciplinary teams. - Organizational skills with a focus on 5S and continuous improvement. **Required Education & Certifications:** - Bachelor’s degree in Manufacturing, Supply Chain, Pharmacy, Engineering, or a related field (or equivalent professional experience). - Minimum 3 years of supply‑chain or warehouse management experience in a GMP‑regulated pharmaceutical environment. - No specific certifications required; proficiency in SAP B1 and eQMS is essential.

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