Senior Manager, Medical Writer

October 24

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Spyre Therapeutics

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Biotechnology • Pharmaceuticals

Spyre Therapeutics is a biopharmaceutical company focused on developing therapies for Inflammatory Bowel Disease (IBD). The company is committed to creating best-in-class antibodies, rational therapeutic combinations, and employing precision immunology approaches to enhance treatment efficacy and convenience for IBD patients. With a team experienced in developing and commercializing treatments across various diseases, Spyre Therapeutics is dedicated to improving treatment options and outcomes for patients through advanced research in immunology. The company fosters a collaborative and innovative environment to achieve its mission of providing promising new treatment options for IBD.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Lead projects, submissions or programs independently. • Provide medical writing strategy to program teams, ensuring business goals and regulatory needs are met. • Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and meeting responses. • Develop timelines in collaboration with our team. Plan for required data with SMEs, if applicable. • Co-author documents with relevant cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments). • Coordinate QC, finalization and publication of documents • Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required. • Ensure key messages are clear and consistent across and within documents. • Represents the medical writing function in cross-functional teams. • Provide status updates to keep teams, department, and leadership informed. • Identify risks and contribute to risk mitigation or contingency planning for submission activities. • Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials. • Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.

🎯 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 8+ years of experience in relevant regulatory medical writing is required. • Proven track record of program- and/or submission-level management • Ability to manage multiple projects and timelines simultaneously • Proven track record of leading and authoring high-quality clinical and regulatory documents, including for complex document types. • 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 (taking initiative, problem solving, conflict resolution, change management, strategic thinking). • Ability to meet deadlines and adapt to changing priorities. • Expert in word processing software (eg, Office) and document management systems (eg, Veeva).

🏖️ 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.