Director, Medical Writing
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.
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
Job Type: Full-Time
Work authorization: United States (Required)
Work Location: Remote
Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.