Description

<div><div>About the Department/Company </div><div>Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. </div><div>Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. </div><div>iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position: </div><div> </div><div>Overview of Job Role </div><div>We are seeking a highly skilled Medical Writer to support scientific and regulatory documentation across the full product lifecycle, from clinical development through registration and postmarketing. The role requires an expert communicator who can translate complex scientific, clinical, and safety data into clear, accurate, and compliant documents for global regulatory authorities, healthcare professionals, and internal stakeholders. The role will have a strong focus on pharmacovigilance-related medical writing. </div><div> </div><div>Scope and responsibility </div><div><ul><li>The Medical Writer is responsible for overseeing all medical writing activities throughout the product lifecycle, spanning from clinical development through the postmarketing phase of our molecules. The role will have a strong focus on pharmacovigilancerelated writing activities. </li></ul></div><div><ul><li>During clinical development, responsibilities include leading the preparation of key clinical documents such as clinical trial protocols, protocol amendments, clinical study reports (CSRs), and development safety sections aligned with the overarching clinical safety strategy. </li></ul></div><div><ul><li>In the postmarketing phase, the Medical Writer guides the development of scientific publications and manages pharmacovigilancerelated writing activities. </li></ul></div><div><ul><li>The Medical Writer will work cross-functionally with Clinical Development, Biostatistics, Pharmacovigilance and other colleagues on data interpretation and presentation. </li></ul></div><div><ul><li>The medical writing activities will include document management to ensure timely delivery. </li></ul></div><div> </div><div> </div><div>Job requirements </div><div><ul><li>MSc/PhD in Life Sciences, PharmD, MD, or related scientific/medical discipline. </li></ul></div></div><div><div><ul><li>Experience in a Medical Writer role with at least 5 years of experience writing documents across multiple lifecycle stages (e.g., IBs, CSRs, protocols, submission documents, safety reports and scientific publications). </li></ul></div><div><ul><li>At least 3 years of experience writing documents relating to pharmacovigilance </li></ul></div><div><ul><li>Excellent scientific storytelling, ability to interpret complex data, and high attention to detail. </li></ul></div><div><ul><li>Demonstrated experience working in multicultural teams. </li></ul></div><div><ul><li>Experience working on biosimilar trials is desirable. </li></ul></div><div><ul><li>Strong knowledge of GCP, global PV regulations and other relevant ICH/regulatory guidelines. </li></ul></div><div><ul><li>Document management system experience is desirable. </li></ul></div></div>

Medical Writer

Description

Alvotech

Pipeline