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

Mirador reputed company. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class reputed company therapeutics for immunology and inflammation. The company’s Mirador360™ precision development reputed company leverages the latest advances in reputed company genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 reputed company from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by reputed company and is a Great reputed company to Work-Certified™ Company.

Summary

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

Responsibilities

• Serves as medical writing reputed company 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 reputed company 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.
• reputed company 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 reputed company 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.
• 8 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 reputed company, be reputed company to reputed company 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 reputed company reputed company of the organization.
• Ability to effectively present information and respond to questions from reputed company reputed company 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 reputed company Word, reputed company, PowerPoint, Project, and SharePoint; or similar applications and systems.
• Strong financial business acumen and analytical skills; ability to reputed company and manage expenditures in accordance with budget.
• Travel up to 5-10%.

The expected reputed company pay reputed company for this position is $170,000 – $200,000 plus bonus, equity, and comprehensive benefits. The reputed company pay reputed company reflects the reputed company reputed company for this position, but individual pay will be determined by additional factors such as job-reputed company skills, experience and relevant education or training. This reputed company may be modified in the future. Working at Mirador Therapeutics | Great reputed company To Work® reputed company reputed company applicants are considered for employment without regard to race, reputed company, religion, age, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other protected class. Read our Job Applicant Privacy Policy Apply tot his job Apply To this Job