Director, Medical Writing

Skip to main content Director, Medical Writing Tyra Biosciences United States Apply Director, Medical Writing Tyra Biosciences United States 1 week ago 57 applicants See who Tyra Biosciences has hired for this role Apply Save Report this job Tyra Biosciences, Inc. is seeking a highly motivated Director of Medical Writing to make impactful contributions to oncology and rare disease drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will be highly organized, self-motivated, able to synthesize and interpret clinical data sets, and thrive in a dynamic, cross-functional start-up environment.The Director of Medical Writing will be an integral member of a growing Medical Writing team, that will work closely with cross-functional development teams and external vendors and consultants to lead and/or contribute to clinical and regulatory deliverables. Experience leading the development of clinical and regulatory documents is required. The successful candidate will also support cross-functional teams to ensure data presentation and messaging is clear and consistent across documents in addition to ensuring timely and compliant document delivery. This is a fully remote position, with opportunities to travel and meet with teams as needed.Must have pharmaceutical and biotech experience. Job Responsibilities:Author or contribute to, review, and manage clinical and regulatory documents including but not limited to:Clinical Study Protocols and AmendmentsInvestigator Brochures (original and updates)Clinical Study Reports (CSRs)Informed Consent Forms (ICFs)Support regulatory briefing documents (meeting requests and briefing packages)Regulatory submission documents (e.g., INDs, NDAs, MAAs)Additionally,Collaborate with internal teams and external vendors to manage timelines and deliverables including quality control (QC) and publishing.Ensure documents comply with ICH guidelines, regulatory requirements, and company standards.Develop and maintain templates, style guides, and best practices for medical writing.QualificationsBachelor’s degree in a scientific field; advanced degree (PhD, PharmD, or MS) preferred8+ years of medical writing experience in the biotech/pharmaceutical industry, including regulatory submissions.Strong knowledge of ICH, FDA, and EMA guidelines and relevant regulationsExcellent writing, editing, and project management skills.Advanced understanding of Microsoft Word, Excel, and Veeva Vault (preferred)Strong knowledge of Smartsheet or an equivalent timeline programAbility to communicate effectively in both a written and verbal formatAbility to work both independently with minimal direction and within project teams to attain group goalsHighly detailed with strong organization skillsAbility to work well in a deadline-driven environment and be flexible in a dynamic environmentTeam oriented personPrior experience managing vendors (and junior medical writers preferred)Fluent in spoken and written EnglishPay Range and BenefitsBase Salary Range: $220,065 - $232,900 USDIndividual compensation will be determined based on factors such as work location, skills, education, training, and experience.What we offer US-based Employees:Competitive base, bonus, new hire and ongoing equity packagesThe starting compensation range(s) for this role is for a full-time employee (FTE) basisBenefit offerings are subject to the terms and conditions of the...