Alvotech is seeking a skilled Technical Writer to join our dynamic team. In this role, you will be responsible for creating comprehensive documentation, including briefing books for health authority interactions, module 3 dossier preparation, and various protocols and reports. You will collaborate with internal teams and subject matter experts (SMEs) to gather necessary information and ensure the accuracy and clarity of all documents. This position is ideal for someone who is detail-oriented, passionate about science, and excels in clear communication.

Key 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.

• Skills:
• 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.

• Attributes:
• Ability to work independently and cross-functionally with various
  
  
  

departments.

• Excellent multitasking skills to handle several projects simultaneously.
• Flexible and can-do attitude.
  
  
  

What we offer:

• 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.
  
  
  

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.