Manager, Medical Writing, Immunology

Overview

In this role you will lead regulatory medical writing for immunology, shaping clinical documents and scientific strategy. You will work within the IDAR Regulatory Medical Writing team to support immunology programs, guiding cross-functional partners and mentoring junior writers. You will drive process improvements, coordinate project timelines, and ensure high-quality submissions that align with regulatory guidelines. This position offers visibility across teams and opportunities to influence how immunology medicines are prepared for life‑changing patient outcomes.

Responsibilities

• Prepare and finalize various clinical documents.
• Lead projects and provide content and scientific direction with independence.
• Set objectives for team members and lead process workgroups.
• Coach and mentor junior staff; oversee writers and external contractors as needed.
• Participate in cross-functional meetings; maintain regulatory knowledge; represent Medical Writing in industry groups.
• Manage direct reports; set development goals; handle hiring and performance discussions.

Key requirements

• University/college degree (Bachelor or higher);Masters or PhD preferred
• At least 8 years of pharmaceutical/scientific experience; at least 6 years in medical writing
• 2 years of people management experience preferred
• Excellent oral and written communication; strong cross-functional engagement
• Expert project/time management and leadership skills
• Ability to interpret and present statistical and medical information accurately
• Regulatory guidance knowledge (ICH) and quality/content standards
• Ability to work independently and build cross-functional relationships

• Attention to detail
• Cross-functional collaboration
• Developing others
• Medical Writing
• Regulatory guidelines (ICH)
• Project management

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