Director, Medical Writing

We are building 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.

We are led by a highly talented executive team with proven experience creating best places to work. We are driven to help patients in need, foster personal and professional growth, unlock our team potential, and to deliver exceptional results.

We offer competitive benefits, pay, time off, and perks!

If you have a passion for being a market leader, discovering and developing disruptive therapies, improving the lives of patients, love what you do and want to help us build a next-generation and best places to work company—we want to hear from you.

Mirador’s commitment to values of trust, ambition, collaboration, integrity, excellence, and ownership shapes our culture of teamwork, innovation, and relentless pursuit of developing transformative precision therapies for patients with immune-mediated diseases.

TRUST

• We trust each other, believing that we all have best intentions and are delivering our part of the collective vision to improve the lives of patients with immune-mediated diseases.
• We hold each other accountable, trusting that we have each other’s backs.
• We trust in the process and feel empowered to address challenges knowing they are part of how we win.

AMBITION

• We think creatively, experiment fearlessly, and develop groundbreaking ideas that benefit our patients.
• Our ambition fuels our moonshot thinking and relentless pursuit of our goals.
• We are empowered to challenge the status quo and seek new solutions to make what seems impossible a reality.

COLLABORATION

• We show up every day knowing that every team member brings unique value and perspective to our shared vision.
• We know that our team output is stronger than the sum of our individual capabilities.
• We encourage active listening, open-mindedness, and constructive feedback across all levels of the organization.

INTEGRITY

• We support each other to make the right decisions and do the right thing.
• We have a commitment to ethical conduct in all aspects of our business.
• Our truth is driven by science and data, which we follow no matter where it leads.

EXCELLENCE

• We expect excellence in all we do.
• We leverage diverse skills and perspectives to achieve excellence in our shared goals.
• Individual excellence is a given; team excellence is our competitive advantage.

OWNERSHIP

• We are invested in the success and reputation of our company, taking ownership in our work with care and commitment.
• We take accountability as a team and as individuals to ensure the right outcomes.
• We are writing the Mirador playbook together, collaborating, executing, and seeking continuous improvement across all levels of the organization.

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
• Manage 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
• Track 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, 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.

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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.