Remote-Eligible Immunology Medical Writing Manager

Regulatory Jobs; Pennsylvania; Hybrid; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Regulatory Medical Writing in Immunology to lead clinical documentation and writing activities within IDAR's Regulatory Medical Writing team. You will drive scientific strategy, mentor staff, and coordinate cross-functional submissions to meet regulatory expectations.

The role requires extensive medical writing experience, strong leadership, and deep regulatory knowledge, with eligibility for remote options on a case-by-case basis.

Qualifications

• Minimum of University/college degree required; Masters/PhD preferred.
• At least 8 years of pharmaceutical/scientific experience; at least 6 years in medical writing.
• 2 years of people management experience preferred.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with independence on content and scientific strategy.
• Guide or train cross-functional team members on processes and best practices.
• May lead project-level writing teams and submissions.
• Proactively recommend departmental process improvements.
• Act as primary point of contact for medical writing activities for the clinical team.
• Coach and mentor junior staff and oversee contractors when needed.
• Maintain knowledge of regulatory guidelines and industry standards.

Skills

Attention to detail

Excellent communication

Project management

Leadership

Cross-functional collaboration

Regulatory knowledge

Clinical writing

Quality validation

SOP practice

Team management

Developing others

Education

Bachelor's degree

Masters or PhD preferred

Job description

Johnson & Johnson is seeking a Manager, Regulatory Medical Writing in Immunology to lead clinical documentation and writing activities within IDAR's Regulatory Medical Writing team. You will drive scientific strategy, mentor staff, and coordinate cross-functional submissions to meet regulatory expectations.

The role requires extensive medical writing experience, strong leadership, and deep regulatory knowledge, with eligibility for remote options on a case-by-case basis.