Manager Medical Writing XTA

Johnson & Johnson Innovative Medicine; Raritan (NJ); Sur place; USD 140 000 - 190 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Cross-functional exposure

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Medical Writing

Regulatory/ICH guidance

Project Leadership

Mentoring / People leadership

Cross-functional collaboration

Formation

Master's degree or PhD in life sciences

Description du poste

Role:

Manager, Regulatory Medical Writing supporting innovative medicine across key therapeutic areas within Johnson & Johnson's IDAR division.

Responsibilities:

prepare and finalize clinical documents, lead and mentor medical writing teams, set project objectives, guide process improvements, and represent Medical Writing in cross-functional and industry groups.

Requirements:

university degree (Master's or PhD preferred), minimum 8 years relevant pharma/scientific experience with at least 6 years in medical writing, submission leadership experience advantageous, and fluency in English.

High-Value:

experience across multiple therapeutic areas, regulatory guidance knowledge (ICH), and proven project leadership skills.

Work setup:

hybrid (3 days onsite weekly) with potential remote options; multiple locations in US and Europe; travel requirements not specified.