Medical Writing Lead
Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Application Deadline: March 23, 2026
Job Requisition ID: JR100099
Experience Required
Minimum 7+ years of experience in medical writing within the pharmaceutical, biotechnology, or clinical research industry, with demonstrated expertise in preparing regulatory and scientific documents across the product lifecycle. Candidates should also have at least 3 years of experience leading or managing a team of medical writers.
Education
MSc or PhD in Life Sciences, Pharmacy, Biomedical Sciences, or a related scientific discipline. Candidates with PharmD or MD qualifications are also encouraged to apply.
Job Overview
Alvotech is seeking an experienced Medical Writing Lead to oversee medical writing activities supporting clinical development, regulatory submissions, and post-marketing documentation. The role requires a highly skilled scientific communicator capable of translating complex clinical, safety, and scientific data into clear, accurate, and regulatory-compliant documents for global health authorities and healthcare stakeholders.
The Medical Writing Lead will play a key leadership role within the integrated Clinical and Medical Research (iCMR) department, guiding medical writing strategy, ensuring high-quality documentation, and managing a growing team of medical writers responsible for biosimilar development programs.
Key Responsibilities
Lead and oversee medical writing activities throughout the product lifecycle, from clinical development to post-marketing phases.
Prepare and review key clinical and regulatory documents including clinical trial protocols, protocol amendments, investigator brochures, and clinical study reports.
Develop clinical development documentation aligned with overall safety and regulatory strategies.
Guide the preparation of regulatory submission documents for global health authorities.
Lead the development of scientific publications and manuscripts during the post-marketing phase.
Manage pharmacovigilance-related medical writing deliverables including safety reports and regulatory safety documentation.
Collaborate closely with cross-functional teams including Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs for data interpretation and scientific communication.
Ensure consistency, accuracy, and compliance of all medical writing deliverables with global regulatory standards.
Oversee document management processes to ensure timely delivery of high-quality documentation.
Manage and coordinate the activities of a team of medical writers, providing leadership, mentoring, and performance guidance.
Support continuous improvement of medical writing processes and documentation standards.
Required Skills and Competencies
Strong expertise in preparing regulatory and scientific documents including protocols, clinical study reports, investigator brochures, submission documents, safety reports, and scientific publications.
Excellent scientific writing and storytelling capabilities with the ability to interpret complex clinical and safety data.
Strong knowledge of Good Clinical Practice (GCP), pharmacovigilance regulations, and ICH regulatory guidelines.
Proven ability to lead teams and manage complex documentation projects within global development programs.
High attention to detail and strong quality control skills in scientific documentation.
Preferred Qualifications
Experience working on biosimilar clinical trials or biosimilar development programs is considered advantageous.
Experience using document management systems in clinical or regulatory environments is desirable.
Professional Skills
Strong leadership and mentoring capabilities.
Excellent communication and stakeholder management skills.
Ability to manage multiple projects and documentation timelines simultaneously.
Strong analytical and organizational skills with a commitment to high-quality scientific communication.
About Alvotech
Alvotech is a global biopharmaceutical company dedicated to the development and manufacturing of high-quality biosimilar medicines. Through scientific innovation and global collaboration, the company aims to improve access to biologic therapies while maintaining the highest standards of regulatory compliance, product quality, and patient safety.
Uttar Pradesh :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Kyiv |Lima Region :
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