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Principal Scientist, Medical Writing
IS10 Alvotech hf
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
Posted 28 okt.
About this role
Scope and responsibilities * Author, review, and coordinate medical writing deliverables across the product lifecycle, from clinical development through the post-marketing phase. * Prepare and coordinate key clinical and regulatory documents, including clinical trial protocols, protocol amendments, clinical study reports, investigator’s brochures, submission documents, and responses to health authority questions. * Author and coordinate pharmacovigilance and safety-related documents, such as aggregate safety reports, risk management documentation, safety sections of regulatory submissions, signal evaluation reports, and other post-marketing safety deliverables. * Work cross-functionally with Clinical Development, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other stakeholders to interpret and clearly present clinical and safety data. * Manage document plans, timelines, review cycles, and stakeholder input to ensure accurate and timely delivery. * Maintain documents and workflows in Veeva Vault or símilar document management systems, ensuring compliance with applicable regulatory requirements, internal procedures, and templates. Job requirements * MSc or PhD in Pharmacy, Life Sciences, or a related scientific or medical discipline; alternatively, a PharmD or MD. * At least 5 years of relevant medical writing experience within the pharmaceutical, biotechnology, or CRO environment, with a minimum of 3 years of experience supporting pharmacovigilance activities. * Demonstrated experience in authoring or coordinating pharmacovigilance and safety-related documents. * Experience in authoring clinical or regulatory documents such as protocols, clinical study reports, investigator’s brochures, submission documents, or responses to health authority questions. * Practical experience with Veeva Vault, preferably Veeva Safety or Veeva RIM, in regulated document authoring, review, approval, and lifecycle workflows. * Strong knowledge of applicable ICH guidelines, GCP, global pharmacovigilance requirements, and medical writing standards. * Ability to interpret and clearly communicate complex clinical and safety data, with excellent scientific writing skills and strong attention to detail. * Strong document-planning skills and the ability to coordinate input from cross-functional and multicultural stakeholders; excellent written and spoken English. * Experience working on biosimilar programs is desirable. At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale. If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide. If you have any technical issues, please contact: hr@alvotech.com