Associate Director, Medical Writing

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

📋 Description

• Author, review, and oversee clinical development and regulatory documents, which include protocols, protocol amendments, clinical study reports (CSRs), investigator brochures, briefing documents, and the clinical sections of regulatory submissions.

• Lead the planning, development, review cycles, and resolution of comments to ensure timely delivery of high-quality outputs.

• Collaborate with Clinical Development, Clinical Operations, Statistics, Clinical Pharmacology, Regulatory Affairs, and other stakeholders to interpret and convey complex scientific, clinical, statistical, and pharmacology data.

• Develop and uphold templates, style guides, document standards, and best practices.

• Ensure adherence to FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and other relevant regulatory requirements.

• Contribute to Investigational New Drug applications (INDs) and other global regulatory submissions, including regulatory responses and accompanying documentation.

• Support initiatives aimed at process improvement that enhances the quality, consistency, and scalability of medical writing.

• Act as a medical writing subject matter expert within cross-functional project teams.

⛳️ Requirements

• A Master's degree or higher in life sciences, pharmacy, nursing, health sciences, or a related scientific field.

• At least 8 years of medical writing experience in the biotechnology, pharmaceutical, or clinical research organization (CRO) sectors.

• Proven expertise in authoring clinical study protocols and clinical study reports.

• Experience in supporting Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), and/or other regulatory submissions.

• Strong knowledge of clinical drug development processes and regulatory requirements.

• Familiarity with clinical pharmacology content is preferred.

• Excellent skills in scientific writing, communication, organization, and project management.

• Capability to manage multiple projects and competing priorities in a dynamic environment.

• Willingness to travel periodically for team meetings and other business requirements.

• Flexibility to accommodate occasional extended hours during times of increased activity and submission-related deadlines.

🏝️ Benefits

• Remote work arrangement.

• Periodic travel for team meetings and other business needs.

• Flexibility to support occasional extended hours during heightened activity and submission-related deadlines.