Associate Director, Principal Medical Writer

Remote Associate Director, Principal Medical Writer working through an FSP model for a Global Oncology focused Pharmaceutical Company The Associate Director, Principal Medical Writer is responsible for developing clinical documents for regulatory submissions worldwide. This role involves leading cross-functional project teams to ensure documents—such as Investigators' Brochures (IBs) and Clinical Study Reports (CSRs)—accurately present clinical data in line with regulatory requirements. Key Responsibilities:Write or supervise the writing of high-quality, scientifically rigorous documents. - Oversee medical writing for multiple compounds and lead regulatory submissions. - Participate in cross-functional meetings to discuss medical writing deliverables and timelines. -Review relevant project documents, such as Protocols and Statistical Analysis Plans. - Mentor junior writers and contribute to process improvement initiatives. Qualifications: A bachelor’s degree is required; an advanced degree is preferred. Minimum 7 years of medical writing experience in the biopharmaceutical or CRO industry. Strong ability to understand and interpret clinical data, with excellent project management skills. - Strong verbal, written, and interpersonal communication skills. - Knowledge of global regulatory requirements and therapeutic areas in clinical development. Proficiency in MS Word and experience with electronic document management systems is essential. This position requires effective interaction with team members and senior leaders to facilitate communication and problem-solving.

Created: 2025-07-23