Senior Manager, Medical Writer
Spyre Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $165,000 - $185,000 per year
Job Level
Senior
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical study protocolsregulatory documentsdata summariesrisk mitigationprocess improvementsdocument templateslean authoringstrategic reviewproject management
Soft skills
leadershipcollaborationcommunicationinterpersonal skillsproblem solvingconflict resolutionchange managementstrategic thinkinginitiativeadaptability
Certifications
Bachelor's degreeMSPhDMDPharmD