Technical Writer - India

Alvotech

Full-time

About the position

Alvotech is looking for a skilled Technical Writer to create comprehensive documentation for health authority interactions and drug product-related documents. This role involves collaboration with internal teams and subject matter experts to ensure clarity and accuracy in all written materials. The ideal candidate should be detail-oriented, passionate about science, and possess strong communication skills.

Responsibilities

• Prepare a variety of documents such as briefing books and IMPD's, module 3 dossier sections, analytical similarity, comparability, and forced degradation protocols and reports, as well as critical quality assessments and other drug product related documents.
• Collaborate with Pharmaceutical Sciences employees and cross-functional teams (e.g., Quality Control, Manufacturing, Regulatory) to gather required information.
• Research, outline, write, and edit new and existing content, ensuring it meets program requirements.
• Independently gather information from SMEs and write documents based on discussions and support from SMEs.
• Utilize and generate templates for different types of documents to streamline future projects.
• Translate source documents into dossier content.

Requirements

• Education: BSc in a scientific subject, preferably Biotechnology or similar.
• Experience: Proven experience in technical report writing, experience in regulatory document writing (module 3) is highly desired.
• Strong scientific background with experience in data gathering, summarizing, and evaluation.
• Proficiency in Word and Excel, including figure generation. Knowledge of additional programs like Prism (GraphPad) and JMP is a plus.
• Understanding of antibody/protein structure and experience with protein manufacturing processes or any PharmSci areas (cell line, upstream, downstream, drug product development, or protein analytics) is beneficial.

Nice-to-haves

• Ability to work independently and cross-functionally with various departments.
• Excellent multitasking skills to handle several projects simultaneously.
• Flexible and can-do attitude.

Benefits

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration, and inclusion.
• Positive, flexible, and innovative work environment.
• A clear and developed organizational structure.
• Training and global opportunities to advance.
• A good work-life balance.
• Home internet and home office equipment.