Content Writer
2 weeks ago
About the Role
We are seeking a skilled Content Writer to join our team as a Biologics Documentation Specialist. In this role, you will be responsible for creating comprehensive documentation, including briefing books for health authority interactions and module 3 dossier preparation.
Key Responsibilities:
- Prepare documents such as briefing books, IMPD's, module 3 dossier sections, analytical similarity, comparability, and forced degradation protocols and reports.
- Collaborate with Pharmaceutical Sciences employees and cross-functional teams to gather required information.
- Research, outline, write, and edit new and existing content, ensuring it meets program requirements.
- Independently gather information from Subject Matter Experts and write documents based on discussions and support.
- Utilize and generate templates for different types of documents to streamline future projects.
- Translate source documents into dossier content.
Requirements:
- Education: Bachelor of Science in a scientific subject, preferably Biotechnology or similar.
- Experience: Proven experience in technical report writing, 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 is beneficial.
- Attributes:
- Ability to work independently and cross-functionally with various departments.
- Excellent multitasking skills to handle several projects simultaneously.
What We Offer:
- A competitive salary of $80,000 per year, reflecting the importance of this role in our organization.
- An inspiring challenge to work with great colleagues 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.
- Clear and developed organizational structure.
- Training and global opportunities to advance.
- Good work-life balance.
- Home internet and home office equipment.
About Us
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
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