Immunology Medical Writing Manager: Lead & Strategy

Johnson & Johnson Co.; Toronto; Remote; CAD 190,000 - 260,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Regulatory Medical Writing in Immunology to lead clinical documentation and cross-functional collaboration within IDAR's Regulatory Medical Writing team. You will guide content strategy, mentor staff, and oversee submission writing for immunology programs.

We expect at least 8 years in pharma/science, with 6 years in medical writing and 2 years of people management; strong writing, leadership, and regulatory knowledge are essential to drive quality,

Qualifications

• Eight+ years of relevant pharmaceutical/scientific experience.
• Six+ years in medical writing.
• Two+ years of people management preferred.
• Strong attention to detail.
• Excellent oral and written communication.
• Solid regulatory guidance knowledge (ICH, etc.).

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with independence and strategy.
• Set objectives for team projects and guide cross-functional groups.
• Coach and mentor junior writers; oversee contractors.
• Lead program-level writing teams or submissions when assigned.
• Recommend process improvements for departmental efficiency.
• Represent Medical Writing in industry standards groups.
• Manage direct reports, set objectives, and develop staff.

Skills

Medical Writing

Leadership

Communication

Project Management

Regulatory Knowledge

Education

Bachelor's degree in a related field

Masters or PhD preferred

Job description

Johnson & Johnson is seeking a Manager, Regulatory Medical Writing in Immunology to lead clinical documentation and cross-functional collaboration within IDAR's Regulatory Medical Writing team. You will guide content strategy, mentor staff, and oversee submission writing for immunology programs.

We expect at least 8 years in pharma/science, with 6 years in medical writing and 2 years of people management; strong writing, leadership, and regulatory knowledge are essential to drive quality,