Senior Medical Writer, Regulatory Affairs

Johnson & Johnson Innovative Medicine; Turnhout; Hybrid; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Career development opportunities

Job summary

Johnson & Johnson Innovative Medicine seeks a Medical Writer III, Regulatory Medical Writing, to support cross-functional regulatory documentation across key therapeutic areas. The role offers hybrid work arrangements with potential location flexibility across Maidenhead, Leiden, Neuss, Paris, Beerse and other sites.

The candidate will lead writing activities, coordinate timelines, and mentor junior staff while ensuring high-quality submissions and regulatory compliance.

Qualifications

• University/college degree in a scientific discipline is required.
• At least 4 years of medical writing experience and 6 years in pharmaceutical/scientific fields.
• Excellent oral and written communication skills in cross-functional settings.
• English fluency required.
• Attention to detail and ability to work in a team.

Responsibilities

• Write or coordinate clinical and regulatory documents (CSRs, IBs, protocols, summaries, RMPs, regulatory responses).
• Lead cross-functional document planning and review meetings; establish timelines and strategies.
• Serve as lead writer for compounds or submissions under supervision; primary point of contact for the team.
• Coach or mentor junior staff on planning, processes and content; provide peer review when needed.
• Participate in or lead process improvement groups and initiatives.

Skills

Medical Writing

Project Management

Regulatory Writing

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Johnson & Johnson Innovative Medicine seeks a Medical Writer III, Regulatory Medical Writing, to support cross-functional regulatory documentation across key therapeutic areas. The role offers hybrid work arrangements with potential location flexibility across Maidenhead, Leiden, Neuss, Paris, Beerse and other sites.

The candidate will lead writing activities, coordinate timelines, and mentor junior staff while ensuring high-quality submissions and regulatory compliance.