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Mirador Therapeutics · 1 week ago

Associate Director, Medical Writing - San Diego, CA or Remote

United States

Full-time

Remote

Lead/Staff, Director/Executive

$170K/yr - $200K/yr

8+ years exp

Mirador Therapeutics is a next-generation precision medicine company focused on immunology and inflammation. The Associate Director, Medical Writing will lead the creation of clinical regulatory documents, ensuring they meet compliance and quality standards while managing timelines and collaborating with cross-functional teams.

BiotechnologyHealth CareMedicalTherapeutics

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

Qualification

Medical WritingClinical Regulatory DocumentsImmunologyInflammationMicrosoft Office SuiteAnalytical SkillsMulti-taskingCommunication SkillsInterpersonal SkillsLeadershipCollaboration

Required

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

8 or more years of experience in Medical Writing

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

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 5-10%