Medical Writer III

Employer Overview

Johnson & Johnson is a leading healthcare innovator, working to prevent, treat and cure complex diseases. Our culture values diversity and inclusion.

Medical Writer III – Regulatory Medical Writing (Immunology)

Hybrid – 3 onsite days per week, with remote work options considered. Primary office:
Spring House, PA / Raritan, NJ / Titusville, NJ / Horsham, PA. Additional locations in High Wycombe, UK;
Leiden, NL;
Beerse, BE;
Allschwil, CH.

• Write and coordinate complex clinical & regulatory documents in Immunology.
• Lead writing efforts for most compounds, under supervision.
• Participate in or lead cross‑functional working groups.
• Provide input into strategy and tactics for medical writing.
• Mentor junior writers.

• Prepare, review and update clinical and regulatory documents: CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Lead cross‑functional document planning and review meetings.
• Set and track document timelines and strategies in line with internal processes.
• Serve as primary point of contact for medical writing activities for the cross‑functional team.
• Coach or mentor junior staff on planning, processes and content.
• Participate in, or lead, process working groups.
• Maintain reporting, training, and metrics in company systems.

• Internal: manager, other writers, clinical, regulatory, biostatistical functions.
• External: contractors or external service providers, partner company staff on co‑developed compounds.

• University or college degree in a scientific discipline (advanced degree preferred).
• At least 6 years of experience in pharmaceutical or scientific industry, with a minimum of 4 years in regulatory medical writing.
• Strong preference for Immunology therapeutic area experience.
• Experience as a compound or submission lead.
• Proficiency in interpreting, summarizing and presenting statistical and medical information.
• Excellent written and spoken English; ability to collaborate with global teams.
• Strong leadership, project and process management skills.
• Attention to detail and ability to resolve complex problems under supervision.
• Demonstrated learning agility and mentorship capability.

Base pay range: $109,000 to $174,800. Eligible for annual performance bonus and company‑sponsored benefits.

• Medical, dental, vision, life insurance and disability.
• Group legal insurance and 401(k) savings plan.
• Vacation up to 120 hours per calendar year.
• Sick time up to 40 hours per year (56 hours in Washington state).
• Holiday pay including floating holidays up to 13 days per year.
• Work‑personal‑family time up to 40 hours per year.

• Cross‑functional partnerships, leads work, medical writing, regulatory writing.

• Business writing, clinical research and regulations, clinical trials operations, coaching, collaboration, communication, copy editing, data synthesis, industry analysis, medical affairs, medical communications, problem solving, process oriented, proofreading, quality standards, research ethics, SOP.