Associate Director Scientific/Medical Writing

Responsibilities

• Write, edit, and format a wide range of high-complexity scientific and regulatory documents for research, clinical development, and post-approval life cycle management.
• Coordinate the document preparation, review, and approval processes across cross-functional teams.
• Check and revise documents to ensure scientific accuracy, completeness, consistency, and compliance with industry standards.
• Manage outsourced medical writing tasks, including SoW setup and coordination of external service providers.
• Foster compliance with international pharmaceutical requirements, including applicable guidelines, regulations, and laws.
• Support the implementation of role-relevant tools, SOPs, templates, and training materials.

Requirements

• M.D., Pharm.D., or Ph.D. in a relevant scientific field.
• 5+ years of hands-on experience in drug development within the pharmaceutical or biotech industry.
• Proven experience as a scientific and medical writer, specifically drafting documents such as CSRs, IBs, and CTD modules.
• Strong knowledge of oncology and/or immunology.
• Deep understanding of regulatory guidelines (e.g., ICH E3, E6, E9, FDA guidance, and EU CTR).
• Native-level proficiency in written and spoken English.
• Excellent attention to detail and the ability to summarize complex scientific results clearly and concisely.

Preferred Qualifications

• Background knowledge in immunology and oncology.
• Experience drafting documents for multiple indications.
• Proficiency in MS 365 (Teams, SharePoint, PowerPoint, Excel) and Adobe Acrobat Pro.
• Knowledge of statistics, trial design, and data reporting for immunotherapeutic agents (e.g., RECIST).
• Good German language skills.

Benefits

• Competitive remuneration packages based on role, location, and experience.
• A dynamic and innovative workplace that values diversity and professional growth.
• The opportunity to contribute to groundbreaking therapies that improve global health outcomes.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing diseases with high medical needs, such as cancer and infectious diseases, through innovative therapeutic approaches.