Full-Time Senior Medical Writer
Spyretherapeutics is hiring a remote Full-Time Senior Medical Writer. The career level for this job opening is Experienced and is accepting USA based applicants remotely. Read complete job description before applying.
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Spyretherapeutics
Job Title
Senior Medical Writer
Posted
Career Level
Full-Time
Career Level
Experienced
Locations Accepted
USA
Salary
YEAR $130000 - $145000
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Job Details
Spyre Therapeutics aims to create next-generation IBD and immune-mediated disease products.
Role Summary: As Senior Medical Writer, you will author and make key contributions to clinical and regulatory documents. You will be responsible for developing high-quality documents that support our clinical studies.
Key Responsibilities:
- Author clinical study protocols, amendments, IBs, and other supporting documents.
- Review or develop document timelines.
- Co-author protocols and IBs with SMEs.
- Manage review cycles and coordinate document finalization.
- Author CSRs and clinical/nonclinical data summaries.
- Work with clinical development, pharmacology, data management, and regulatory affairs teams.
- Identify risks and contribute to risk mitigation.
- Contribute to the maintenance of document templates and training materials.
- Advocate for industry best practices.
Ideal Candidate:
- Bachelor's degree in a scientific discipline. Advanced degree is a plus.
- 4+ years of regulatory medical writing experience.
- Proven track record of leading development of clinical study documents.
- Strong knowledge of global pharmaceutical regulations.
- Excellent leadership, collaboration, and communication skills.
- Ability to meet deadlines and adapt to changing priorities.
What We Offer:
- Opportunity to work in a fast-paced environment.
- Market competitive compensation and benefits.
- Unlimited PTO.
- Remote working environment.
Skills
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Senior Medical Writer at Spyretherapeutics is
8th of November 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
USA
] applicants. .
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