Director, Medical Writing

Overview

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.

TheDirector 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 Amendments
• Investigator 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.

Qualifications

• Bachelor’s degree in a scientific field; advanced degree (PhD, PharmD, or MS) preferred
• 8+ years of medical writing experience in the biotech/pharmaceutical industry, including regulatory submissions.
• Strong knowledge of ICH, FDA, and EMA guidelines and relevant regulations
• Excellent writing, editing, and project management skills.
• Advanced understanding of Microsoft Word, Excel, and Veeva Vault (preferred)
• Strong knowledge of Smartsheet or an equivalent timeline program
• Ability to communicate effectively in both a written and verbal format
• Ability to work both independently with minimal direction and within project teams to attain group goals
• Highly detailed with strong organization skills
• Ability to work well in a deadline-driven environment and be flexible in a dynamic environment
• Team oriented person
• Prior experience managing vendors (and junior medical writers preferred)
• Fluent in spoken and written English

Pay Range and Benefits

Base Salary Range : $220,065 - $232,900 USD

Individual 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 packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance