Associate 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 other regulatory submissions.

• Collaborate with authors, contributors, and reviewers from Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs to gather document input.

• Oversee document review processes and schedules, and facilitate meetings to meet documentation timelines.

• Manage medical writing timelines for assigned documents and ensure timely deliverables that align with business requirements.

• Assist in resolving comments and adjudicating feedback with authors, reviewers, and project teams.

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

⛳️ Requirements

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

• A minimum of 8 years of experience in regulatory medical writing within the pharmaceutical industry or a related organization.

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

• Familiarity with higher-level summary documents.

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

• Capability to write and edit complex materials for accuracy, clarity, consistency, and effectiveness.

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

• Excellent communication skills with the ability to engage effectively in a cross-functional environment.

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

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

• Comfort in a fast-paced small company environment with minimal direction and shifting priorities.

• Demonstrated initiative and the capability to manage multiple projects simultaneously with minimal guidance.

• Ability to think strategically, be resourceful, and lead with minimal supervision.

• Knowledge of oncology disease areas is preferred.

🏝️ Benefits

• Potential bonus.

• Stock options.

• Benefits and/or other applicable variable compensation.