Principal Medical Writer
October 26
Description
• Spyre Therapeutics is a clinical-stage biotechnology company focused on IBD products. • As Principal Medical Writer, lead key clinical and regulatory documents. • Develop study protocols, reports, and regulatory submissions. • Collaborate with SMEs across various departments to meet timelines. • Manage the development of high-quality documents and advocate for best practices.
Requirements
• Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD, MD, PharmD) is a plus. • A minimum of 6+ years of experience in pharmaceutical medical writing and/or related disciplines (note: advanced degree + fewer years of experience will be considered). • Proven track record of successfully managing clinical study protocols, their amendments, study reports, investigator’s brochures, and other key clinical and regulatory submission documents. • Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements. • Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus. • Excellent 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.
Benefits
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.
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