Senior Medical Writer — Regulatory (Hybrid)

Johnson Johnson; High Wycombe; Hybrid; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Flexible working environment

Career development opportunities

Job summary

Johnson & Johnson Family of Companies seeks a Medical Writer III, Regulatory Medical Writing, to support across key therapeutic areas within the IDAR unit. Hybrid work (3 days onsite weekly) and possible case-by-case remote options are offered; multiple country postings exist.

You will write critical regulatory documents, lead cross-functional planning, and mentor junior staff. The role requires a scientific degree, 6+ years in pharma/science with 4+ years in medical writing, and strong English

Qualifications

• A university/college degree in a scientific discipline is required.
• An advanced degree (eg, Masters, PhD, MD) preferred.
• At least 6 years of pharma/scientific experience with at least 4 years in medical writing.
• Excellent oral and written communication skills are pivotal.
• English fluency required.

Responsibilities

• Write or coordinate clinical and regulatory documents such as CSRs, IBs, protocols, summaries, RMPs and regulatory responses.
• Lead cross-functional document planning and review meetings with timelines and strategies.
• Function as lead writer for compounds or submissions under supervision and mentor junior staff.
• Coach or mentor on document planning, processes and content; provide peer review as needed.
• Participate in or lead process working groups.

Skills

Medical writing

Regulatory writing

Cross-functional collaboration

Project management

Attention to detail

Education

Scientific degree

Job description

Johnson & Johnson Family of Companies seeks a Medical Writer III, Regulatory Medical Writing, to support across key therapeutic areas within the IDAR unit. Hybrid work (3 days onsite weekly) and possible case-by-case remote options are offered; multiple country postings exist.

You will write critical regulatory documents, lead cross-functional planning, and mentor junior staff. The role requires a scientific degree, 6+ years in pharma/science with 4+ years in medical writing, and strong English