What are the responsibilities and job description for the Director, Medical Writing position at Mirador Therapeutics, Inc.?

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360

precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.

Summary

The Director, Medical Writing, within the Regulatory Affairs and Quality organization, will author high-quality, strategically aligned clinical regulatory documents supporting the regulatory requirements of clinical development programs, ensuring completeness, accuracy, and compliance.

Responsibilities

Serves as medical writing lead on clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, and IND and NDA modules
Collect and interpret data, analyze published literature, define problems, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions
Represent Medical Writing in assigned project meetings and provide guidance to cross‑functional project teams as appropriate
Serve as Medical Writing contact for external parties (for example, CROs) involved in the conduct of global clinical trials
Manages multiple and overlapping document timelines in a dynamic environment
Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner
Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed
Communicate project updates and risks to senior regulatory management and stakeholders across the organization
Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
Contribute to responses to requests for information from health authorities

Experience and Qualifications

PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline

10 or more years of experience in Medical Writing; experience in therapeutic areas of immunology and inflammation preferred

Ability to prepare any type of clinical regulatory document (e.g., protocol, Clinical Study Reports (CSR), Investigator’s Brochure (IB), clinical sections of Investigational Medicinal Product Dossier and Common Technical Document (IMPD and CTD / eCTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format.

Skills and Abilities

Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards

Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization

Ability to effectively present information and respond to questions from all levels of the organization

Sense of urgency, focus on accuracy and accountability

Self-starter, highly motivated, assertive, driven, and hands-on leader

Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment

Operate collaboratively with colleagues across functional areas in a science-driven environment

Ability to work well under pressure and meet time sensitive deadlines

Ability to work across locations and time zones

Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems

Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget

Travel up to 10%

The expected base pay range for this position is $175,000 - $220,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.

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Salary : $175,000 - $220,000

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Director, Medical Writing

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