Full-Time Senior Medical Writer

Spyre Therapeutics is a biotechnology company focused on next-generation inflammatory bowel disease (IBD) and other immune-mediated diseases. We use advanced antibody engineering, targeted therapeutic combinations, and precision medicine.Role Summary: As a Senior Medical Writer, you will contribute to clinical and regulatory documents. You'll develop high-quality documents supporting clinical studies (protocols, amendments, CSRs, IBs, annual reports/DSURs). You'll also review ICFs, briefing documents, and regulatory responses. Collaborating with cross-functional SMEs, you'll manage projects from start to finish, advocating for best practices.

Key Responsibilities:

• Author clinical study protocols, amendments, IBs, and supporting documents.
• Review/develop timelines for clinical documents with team and CROs, ensuring timely completion for regulatory submissions and study execution.
• Co-author protocols and IBs with SMEs, ensuring compliance with ethical and regulatory standards.
• Manage review cycles and coordinate finalization/publication of documents.
• Author CSRs and data summaries for INDs, CTAs, BLAs, and MAAs, collaborating with clinical development, translational science, and regulatory affairs teams.
• Co-author robust CSR shells in preparation for database lock(s).
• Prepare written summaries for regulatory submissions, ensuring clarity and consistency.
• Coordinate data integrity reviews of CSRs, ensuring consistency with raw data and TLFs.
• Identify risks and contribute to risk mitigation/contingency planning.
• Contribute to document templates, job aids, and training materials.
• Implement industry best practices (e.g., lean authoring, strategic review).
• Other duties as assigned.

Ideal Candidate:

• Bachelor's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) preferred; advanced degree (MS, PhD, MD, PharmD) a plus.
• 4+ years of regulatory medical writing experience in biotech/pharma.
• Proven track record managing clinical study documents.
• Strong knowledge of global pharmaceutical regulations (FDA, EMA, ICH).
• Knowledge of combination products (drug-drug/biologic-biologic) a plus.
• Strong leadership, collaboration, communication, and interpersonal skills.
• Strong problem-solving and critical thinking abilities.
• Ability to meet deadlines and adapt to changing priorities.
• Proficiency in word processing software and document management systems.

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