Associate Director, Medical Writing

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

📋 Description

• Primary author responsible for drafting phase 1-4 protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), master Informed Consent Forms (ICFs), eCTD modules for Investigational New Drugs (INDs) and Biologics License Applications (BLAs), as well as briefing documents for scientific consultations, specialized regulatory documents including Pediatric Investigation Plans (PIPs), Orphan Drug Designations (ODDs), aggregate reports, Requests for Information (RFIs), and other essential documents for drug development.

• Collaborates with relevant Subject Matter Experts (SMEs) and document owners to create content that is organized, consistent, precise, and suitable for a regulatory audience.

• Accountable for ensuring the inspection-readiness of all medical writing activities.

• Promotes the standardization of documents by utilizing document templates, lexicons, and the argenx style guide to maintain the quality and uniformity of documents across various programs.

• Oversees medical writers (including in-house Full-Time Equivalents, contractors, and external vendors) who contribute to the medical writing efforts for a diverse range of regulatory documents.

• Works in partnership with project teams, including program leaders, clinical study managers, biostatisticians, and medical directors, to guarantee that project timelines are adhered to.

• Implements corporate objectives, goals, metrics, and strategies while also contributing to their development.

• Demonstrates capability to manage multiple deliverables at the same time.

⛳️ Requirements

• A Bachelor’s degree in a scientific or clinical discipline or a related field is required; a PhD is preferred.

• A minimum of 5 years of relevant experience in sponsor-level pharmaceutical or biotech clinical/regulatory medical writing is required; experience in Contract Research Organizations (CROs) will be considered.

• Proficiency in American English, either as a native speaker, bilingual, or fluent.

• Experience in solution-focused eCTD Module 5 and Module 2 writing for global Marketing Authorization Applications (MAAs).

• A foundational understanding of scientific methodologies as they relate to drug development, encompassing the phases, processes, and techniques utilized within a clinical development context from protocol design through to regulatory submission.

• Familiarity with the regulatory guidelines relevant to documents produced by medical writing.

• Capability to proofread documents to ensure compliance with both internal and external guidance documents.

• Exceptional written and verbal communication skills are required.

• Proficiency in Microsoft Office is essential.

• Experience with Veeva Vault and Please Review is preferred.

• Knowledge of pharmacovigilance documents is preferred.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development

• Wellness programs