About The Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.
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.
Overview Of Job Role
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:
We are seeking a highly skilled Medical Writing Lead 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 Medical Writing Lead will be leading the growing team of Medical Writers.
Scope and responsibility
- The Medical Writing Lead is responsible for overseeing all medical writing activities throughout the product lifecycle, spanning from clinical development through the postmarketing phase of our molecules.
- 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.
- In the postmarketing phase, the Medical Writing Lead guides the development of scientific publications and manages pharmacovigilancerelated writing activities.
- The Medical Writing Lead will work cross-functionally with Clinical Development, Biostatistics, Pharmacovigilance and other colleagues on data interpretation and presentation.
- The medical writing activities will include document management to ensure timely delivery.
- As part of the overall responsibilities, the Medical Writing Lead will be managing the growing team of medical writers and will coordinate activities for the team.
Job Requirements
- MSc/PhD in Life Sciences, PharmD, MD, or related scientific/medical discipline.
- Experience in a Medical Writer role with at least 7 years of experience writing documents across multiple lifecycle stages (e.g., IBs, CSRs, protocols, submission documents, safety reports and scientific publications).
- At least 3 years of experience working as a Team Lead overseeing other medical writers.
- Excellent scientific storytelling, ability to interpret complex data, and high attention to detail.
- Demonstrated experience working in multicultural teams.
- Experience working on biosimilar trials is desirable.
- Strong knowledge of GCP, global PV regulations and other relevant ICH/regulatory guidelines.
- Document management system experience is desirable.
