Not specified (assumed to be hybrid or fully remote based on industry norms).
Scientific and regulatory documentation
Clinical development through registration
Translate complex data
Alvotech is seeking a Medical Writing Lead to oversee scientific and regulatory documentation across the product lifecycle, focusing on biosimilar medicines. The ideal candidate will have extensive experience in medical writing and leadership, with a strong understanding of regulatory requirements
Job Summary
The Medical Writing Lead will be responsible for overseeing all medical writing activities throughout the product lifecycle, spanning from clinical development through the post marketing phase of our molecules.
Responsibilities include leading the preparation of key clinical documents such as clinical trial protocols, protocol amendments, clinical study reports (CSRs), and development safety sections.
The Medical Writing Lead will be managing the growing team of medical writers and will coordinate activities for the team.
Matching Summary
Match Score: 85
Alvotech is seeking a Medical Writing Lead to oversee scientific and regulatory documentation across the product lifecycle, focusing on biosimilar medicines. The ideal candidate will have extensive experience in medical writing and leadership, with a strong understanding of regulatory requirements.
Skills & Requirements
Must-have
scientific and regulatory documentation
clinical development through registration
translate complex data
global regulatory authorities
cross-functional collaboration
document management system experience
Nice-to-have
excellent scientific storytelling
working in multicultural teams
experience working on biosimilar trials
Key Requirements
MSc/PhD in Life Sciences, PharmD, MD, or related scientific/medical discipline