Senior Regulatory Medical Writing Lead - Hybrid/Remote

Johnson & Johnson Innovative Medicine; Raritan (NJ); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Cross-functional exposure

Job summary

Johnson & Johnson's IDAR division seeks a Manager, Regulatory Medical Writing to oversee the preparation and finalization of clinical documents across key therapeutic areas.

This hybrid role requires guiding processes, mentoring teams, and participating in cross-functional groups; US and Europe locations with onsite 3 days a week. Candidates should have advanced degrees and extensive pharma writing experience.

Qualifications

• Minimum 8 years pharma/scientific experience with at least 6 in medical writing.
• Submission leadership experience advantageous.
• Fluency in English.

Responsibilities

• Prepare and finalize clinical documents.
• Lead and mentor medical writing teams.
• Set project objectives and guide process improvements.
• Represent Medical Writing in cross-functional/industry groups.

Skills

Medical Writing

Regulatory/ICH guidance

Project Leadership

Mentoring / People leadership

Cross-functional collaboration

Education

Master's degree or PhD in life sciences

Job description

Johnson & Johnson's IDAR division seeks a Manager, Regulatory Medical Writing to oversee the preparation and finalization of clinical documents across key therapeutic areas.

This hybrid role requires guiding processes, mentoring teams, and participating in cross-functional groups; US and Europe locations with onsite 3 days a week. Candidates should have advanced degrees and extensive pharma writing experience.