Director, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare, edit, and finalize clinical and regulatory documents such as protocols and amendments, clinical study reports, Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and additional regulatory submissions.

• Collaborate with document authors, contributors, and reviewers from various departments including Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs.

• Oversee the document review processes and schedules, and conduct meetings to ensure documentation timelines are met.

• Develop and manage timelines for medical writing concerning assigned documents, ensuring timely deliverables.

• Facilitate the resolution of comments and adjudication with authors, reviewers, and project teams.

• Engage in the development and refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides.

• Carry out additional duties as assigned.

⛳️ Requirements

• A BA/BS degree in a scientific discipline is required; an advanced scientific degree (PhD, PharmD, or MS) is preferred.

• Over 10 years of regulatory medical writing experience within the pharmaceutical industry or a related organization.

• Proven experience in writing clinical study protocols, clinical study reports, investigator’s brochures, and the clinical sections of IND submissions and NDAs.

• A solid understanding of the content within higher-level summary documents.

• Knowledge in oncology disease areas is preferred.

• Exceptional writing skills with a comprehensive understanding of the drug development process and relevant regulatory guidelines.

• Ability to compose and edit complex materials for accuracy, clarity, consistency, and efficacy.

• Strong attention to detail, multitasking abilities, prioritization skills, and flexibility.

• Excellent communication skills with the capability to interact effectively in a cross-functional environment.

• Ability to critically analyze and synthesize complex scientific information from diverse scientific disciplines and clinical therapeutic areas.

• Proficient in MS Office applications, Adobe Acrobat, electronic document management systems, and templates.

• Comfortable working in a fast-paced small company environment with minimal supervision and adapting to changing priorities.

• Demonstrated initiative with the ability to manage multiple projects concurrently with little guidance.

• Capacity to think strategically, exhibit resourcefulness, and lead with minimal oversight.

🏝️ Benefits

• Potential bonus.

• Stock options.

• Comprehensive benefits package.

• Other applicable variable compensation.