Medical Writer
Company: Alvotech
Location: Stockholm Office / Sweden Home Office (Partially Remote)
Job Type: Full-Time
Application Deadline: March 25, 2026
Job Requisition ID: JR100055
Experience Required
Minimum 5+ years of experience in medical writing within the pharmaceutical, biotechnology, or clinical research industry. Candidates should have proven experience preparing regulatory and scientific documents across multiple product lifecycle stages including clinical development and post-marketing activities.
Education
MSc or PhD in Life Sciences, Pharmacy, Biomedical Sciences, or related disciplines. Candidates with PharmD or MD qualifications are also encouraged to apply.
Job Overview
Alvotech is seeking an experienced Medical Writer to support scientific and regulatory documentation throughout the full product lifecycle, from early clinical development to regulatory submissions and post-marketing activities. The role requires strong scientific communication skills to transform complex clinical, safety, and regulatory data into clear, accurate, and compliant documents for global regulatory authorities, healthcare professionals, and internal stakeholders.
The Medical Writer will work closely with multidisciplinary teams within the integrated Clinical and Medical Research (iCMR) department, contributing to clinical development strategies and supporting the successful development of biosimilar medicines.
Key Responsibilities
Lead and manage medical writing activities across the entire product lifecycle, from clinical development through post-marketing stages.
Prepare and review key clinical and regulatory documents including clinical trial protocols, protocol amendments, investigator brochures, and clinical study reports.
Develop development safety documentation aligned with the overall clinical safety strategy.
Support the preparation of regulatory submission documents required for global health authority submissions.
Guide the development of scientific publications and manuscripts during the post-marketing phase.
Manage pharmacovigilance-related medical writing activities including safety reports and regulatory documentation.
Collaborate with cross-functional teams including Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs for data interpretation and presentation.
Ensure scientific accuracy, regulatory compliance, and consistency across all medical writing deliverables.
Manage documentation timelines and ensure timely delivery of high-quality scientific documents.
Translate complex clinical, safety, and scientific data into clear and concise documentation suitable for global regulatory authorities and healthcare professionals.
Required Skills and Competencies
Strong expertise in preparing regulatory and scientific documentation including protocols, CSRs, submission documents, safety reports, and scientific publications.
Excellent scientific writing and storytelling skills with the ability to interpret complex clinical data.
Strong knowledge of Good Clinical Practice (GCP), global pharmacovigilance regulations, and ICH regulatory guidelines.
High attention to detail and strong document quality management capabilities.
Ability to work effectively in multicultural and multidisciplinary global teams.
Preferred Qualifications
Experience working on biosimilar clinical trials or biosimilar development programs is considered an advantage.
Experience with document management systems used in regulatory or clinical environments is desirable.
Professional Skills
Strong analytical and problem-solving abilities.
Excellent communication and collaboration skills.
Ability to manage multiple complex documents and deadlines simultaneously.
High level of organization and attention to detail in scientific documentation.
About Alvotech
Alvotech is a global biopharmaceutical company specializing in the development and manufacturing of high-quality biosimilar medicines. The company focuses on expanding patient access to biologic therapies through scientific innovation, strong regulatory expertise, and global clinical development programs.
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