Associate Director, Principal Medical Writer

RemoteAssociate Director, Principal Medical Writerworking 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.