Job Title: Principal Medical Writer II

Job Description

The Associate Director, Principal Medical Writer II is responsible for developing clinical documents for submissions to regulatory authorities globally. You will provide strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents, such as Investigators' Brochures, Clinical Study Reports, and marketing authorization submission documents, accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. In this role, you will write or provide direction and leadership to other writers, ensuring the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and feature accurate data presentation and interpretation. You will oversee the medical writing activities of multiple compounds and serve as the lead writer for individual summary documents. You will have a broad understanding of clinical research processes and global regulatory document standards and will mentor less experienced writers.

Responsibilities

• Develop clinical documents for global regulatory submissions.
• Provide strategic direction to cross-functional project teams.
• Ensure clinical documents accurately present key data-driven messages.
• Write and direct the creation of high-quality scientific documents.
• Oversee medical writing activities for multiple compounds.
• Serve as lead writer for individual summary documents.
• Mentor less experienced writers.

Essential Skills

• Technical writing and medical writing expertise.
• Bachelor's degree required; advanced degree preferred.
• At least 7 years of medical writing experience in the biopharmaceutical/CRO industry.
• Experience leading submissions for marketing approval.
• Proficiency in organizing and communicating clinical information.
• Strong organizational, time management, and project management skills.
• Strong verbal, written, and interpersonal communication skills.

Additional Skills & Qualifications

• Experience with MS Word and StartingPoint templates.
• Knowledge of FDA and EMA regulatory requirements.
• Experience with all phases of clinical trials, I-IV.
• Experience in both CRO and sponsor environments.
• Focus on oncology and immunology therapeutic areas.

Work Environment

This role is 100% remote, offering the flexibility to work from anywhere in the EST time zone for US-based individuals. The position is fully allocated at 40 hours a week, with a laptop provided. You will be working primarily on writing summary documents and Clinical Study Reports, as well as overseeing document writing outsourced to third parties.