Manager, Medical Writing, Immunology

Manager-level medical writing position within the Immunology therapeutic area, reporting to the Regulatory Medical Writing team. The role involves preparing clinical documents, leading writing teams, mentoring junior staff, and managing direct reports while maintaining regulatory compliance.

Responsibilities

• Prepare and finalize all types of clinical documents for Immunology programs
• Lead medical writing teams, set objectives, and manage direct reports including hiring and performance discussions
• Coach and mentor junior medical writers on document planning, processes, and provide peer review
• Serve as primary point of contact for medical writing activities on assigned clinical programs
• Participate in cross-functional meetings and recommend departmental process improvements

Requirements

• University or college degree minimum; Master's or PhD preferred
• At least 8 years pharmaceutical or scientific experience
• At least 6 years medical writing experience required
• 2 years people management experience preferred
• Strong knowledge of ICH requirements and regulatory guidance documents
• Expert project and time management skills with complex problem-solving ability
• Excellent written and oral communication for cross-functional engagement