About the Role:

Reporting to the Chief Development and Operations Officer, the Director/Sr. Director of Medical Writing will play a pivotal role on IDRx’s growing team by standing up the medical writing function at the company. This role will allow you to lead the function, but continue to be hand-on with all of the work that needs to be accomplished. This role is fully remote, but the IDRx team meets in-person in Boston once per month.

Responsibilities:

• Establish, develop and lead the Medical Writing function at IDRx.
• Create and define any procedures, work instructions, timelines, document tools and templates, style guide, and best practices.
• Author important strategic internal documents or documents with high internal subject matter expertise required such as briefing books, protocols, ethics responses, informed consents, etc.
• Ensure key messages are clear and consistent within and across documents.
• Oversee vendor(s) or contract medical writers as the internal IDRx lead and ensure internal alignment and comment resolution of documents such as DSURs, IBs, and Clinical Study Reports.
• Author NDA sections and work closely with subject matter experts (in later development, as applicable).
• Author IND sections and work closely with subject matter experts for any new product candidates.
• Ensure documents are in accordance with ICH as well as other regulatory guidelines.
• Other duties, as assigned.

Requirements:

• At least 5-7 years of experience in medical writing, specifically with clinical and regulatory documents
• Bachelor’s degree required; MS or PhD preferred
• Oncology experience is a must
• Rare disease experience a plus
• Expert knowledge of US and international regulations, requirements, and guidance