Job details

Associate Director, Medical Writer

Spyre Therapeutics is a clinical-stage biotechnology company developing long-acting antibodies and antibody combinations for IBD and rheumatic diseases. The Associate Director, Medical Writer will lead and contribute to clinical and regulatory documents across programs, provide medical writing strategy, manage document timelines and quality, and collaborate with cross-functional SMEs and external writers to support submissions.

Skills

8+ years regulatory medical writing for clinical development and submissions
Proven program- or submission-level project management experience
Strong knowledge of FDA, EMA, and ICH guidelines and global regulatory requirements
Experience authoring complex documents (protocols, IBs, CSRs, CTD summaries, briefing books)
Proficiency with MS Office and document management systems (e.g., Veeva)
Ability to work with cross-functional teams and manage multiple timelines
Excellent written and verbal communication and leadership skills

Responsibilities

Lead authorship and project management for clinical, nonclinical, and regulatory documents (protocols, IBs, CSRs, CTD summaries, briefing books, meeting responses)
Provide medical writing strategy and planning to program teams and ensure regulatory compliance
Coordinate review cycles, QC, finalization, and publication of documents; manage timelines and stakeholder feedback
Collaborate with cross-functional SMEs to ensure clear, consistent key messages across documents
Oversee and coordinate contract medical writers and external writing resources as needed
Represent medical writing in cross-functional teams and provide status updates to leadership
Identify risks for submission activities and contribute to mitigation and contingency planning
Contribute to process improvements, templates, job aids, and training; advocate best practices (e.g., lean authoring)

Education

Bachelor's degree in a scientific discipline (Pharmacy, Chemistry, Biology, or related)
Advanced degree (MS, PhD, MD, PharmD) preferred but not required

Benefits

Market-competitive base salary with performance bonus and equity grant opportunities
Health, welfare, and retirement benefits
Unlimited PTO and two one-week company-wide shutdowns annually
Remote work with periodic in-person meetings
Professional development and training opportunities

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Medical Writing Regulatory Clinical Protocol CSR CTD FDA EMA ICH Veeva Biologics Project Management Clinical Development IBD Long-acting Antibodies

Average salary estimate

$187500 / YEARLY (est.)

min

max

$175000K

$200000K

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