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Technical Writer
2 weeks ago
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 Regulatory and Technical Documentation
Develop a wide range of documents including briefing books for health authority meetings, Module 3 dossiers, critical quality assessments, risk ranking reports, and protocols and reports related to process development and validation. - Collaborate Across Teams
Partner with internal stakeholders to gather necessary information, engaging with Pharmaceutical Sciences personnel and cross-functional teams such as Program Management, Quality Control, Manufacturing, and Regulatory Affairs. - Content Development and Editing
Research, structure, write, and revise both new and existing documentation. Work closely with various departments to ensure alignment with program objectives and regulatory expectations. - Engage Subject Matter Experts (SMEs)
Independently source and synthesize information from SMEs to support document creation. Maintain ongoing dialogue to ensure accuracy and completeness. - Template Management
Apply appropriate templates tailored to the target audience. Create and maintain document templates to streamline future projects and ensure consistency. - Dossier Translation
Convert source materials into high-quality dossier content suitable for regulatory submission.
Qualifications:
- Education: BSc in a scientific subject, preferably Biotechnology or similar.
- Experience: Proven experience in technical report writing, experience i 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.
- 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.
