Manager/Sr Manager, Medical & Scientific Writing (Biopharmaceutical)

Location: Malvern, Pennsylvania, United States; office-based and in person

No salary information provided.

Company

hirify.global is a biopharmaceutical company developing clinical programs, including biologic and gene therapy products.

What you will do

• Author, analyze, and integrate CMC, nonclinical toxicology, preclinical efficacy, clinical, and regulatory data into submission documents.
• Prepare and support Pre-IND, IND, BLA, DSUR, IMPD, Orphan Drug Designation, and RMAT submissions.
• Perform editorial and quality-control reviews to ensure accuracy, consistency, structure, and clarity.
• Manage document review workflows, approval processes, timelines, and responses to regulatory agency queries.
• Develop protocols, guidance documents, scientific presentations, manuscripts, clinical study reports, abstracts, and publications.
• Coordinate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, manufacturing, and quality functions.

Requirements

• PhD with more than 3 years of relevant experience, or a bachelor's/master's degree in life sciences with 6–10 years of medical or technical writing experience in the biopharmaceutical industry.
• Demonstrated excellence in scientific writing and the ability to communicate complex data clearly and accurately.
• Experience working with cross-functional clinical, regulatory, biostatistics, manufacturing, and quality teams.
• Strong understanding of scientific principles, research methodologies, drug development, and global regulatory requirements.
• In-depth knowledge of regulatory submission processes and BLA submissions.
• Proficiency in Microsoft Word, PowerPoint, SharePoint, and structured collaborative authoring templates.

Nice to have

• Experience with biologics or gene therapy products.
• Knowledge of ophthalmology or neuroscience.
• Familiarity with illustration, visualization, and AI tools or platforms.

Culture & Benefits

• Office-based, in-person work environment.
• Availability outside regular working hours may be required for priority business needs.
• Full-time position.