Regulatory Medical Writer II - Hybrid, Global Trials

Johnson Johnson; Beerse; Hybrid; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Competitive salary

Extensive benefits package

Vacation days

Disability accommodation

Job summary

Johnson & Johnson in Beerse, Belgium, is seeking a Medical Writer II, Regulatory Medical Writing to support multiple therapeutic areas within our IDAR group. The role is Hybrid (3 days onsite weekly) with remote possibilities on a case-by-case basis.

The position involves authoring diverse regulatory documents, coordinating cross-functional teams, and contributing to process improvements while offering growth and mentorship opportunities in a global pharma environment.

Qualifications

• University/college degree in a scientific discipline is required; advanced degree preferred.
• 2+ years of pharmaceutical/scientific experience.
• 2–4+ years of regulatory medical writing experience.
• Strong oral and written English communication.
• Ability to work in a team and manage time effectively.

Responsibilities

• Writing and coordinating basic clinical documents such as Phase 1 protocols and Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writing, contributing to, and/or coordinating low to medium complexity clinical and regulatory documents such as Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performing document QC, completing lists of abbreviations or references, conducting literature searches, and performing other basic tasks with supervision as needed.
• Participating in and may be leading cross-functional document planning and review meetings. Working in a team environment with some guidance while increasing independence for longer-term activities.
• Taking an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacting with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

Skills

Medical Writing

Regulatory Writing

English Writing

Cross-Functional Teamwork

Time Management

Documentation Skills

Education

Bachelor's degree in scientific discipline

Advanced degree (Masters/PhD/MD) preferred

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Johnson & Johnson in Beerse, Belgium, is seeking a Medical Writer II, Regulatory Medical Writing to support multiple therapeutic areas within our IDAR group. The role is Hybrid (3 days onsite weekly) with remote possibilities on a case-by-case basis.

The position involves authoring diverse regulatory documents, coordinating cross-functional teams, and contributing to process improvements while offering growth and mentorship opportunities in a global pharma environment.