Medical Writer III

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Medical Affairs Group

Job Sub Function

Medical Writing

Job Category

Professional

Locations

Horsham, Pennsylvania; Raritan, New Jersey; Spring House, Pennsylvania; Titusville, New Jersey (United States); High Wycombe, United Kingdom; Leiden, The Netherlands; Beerse, Belgium; Allschwil, Switzerland.

Role Overview

We are searching for the best talent to join our Regulatory Medical Writing team, part of Integrated Data Analytics & Reporting (IDAR), to support our Immunology therapeutic area. This is a hybrid position (3 days per week onsite, 2 days work from home). Remote work options may be considered on a case-by-case basis.

Purpose

• Write and coordinate basic and complex documents, independently within own therapeutic area (TA), and under supervision across TAs.
• Lead in a team environment and matrix.
• Function as a lead MW on most compounds, under supervision.
• Actively participate in or lead process working groups.
• Provide input into functional tactics/strategy.
• Highly proficient in the use of internal systems, tools, and processes.

Responsibilities

• Write or coordinate clinical and regulatory documents such as CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Lead cross-functional document planning and review meetings.
• Establish document timelines and strategies in accordance with internal processes.
• Complete all time reporting, training, metrics database, and project tracking updates.
• Serve as the primary point of contact for medical writing activities for the cross-functional team.
• Coach or mentor more junior staff on document planning, processes, and content.
• Provide peer review as needed.

Principal Relationships

• Internal: Manager, writers, and cross-functional contacts (clinical, regulatory, biostatistics).
• External: May interact with or oversee contractors/external service providers and collaborate with external partner company staff.

Education and Experience Requirements

• University/college degree in a scientific discipline required; advanced degree (Masters, PhD, MD) preferred.
• At least 6 years of relevant pharmaceutical/scientific industry experience, including at least 4 years of regulatory medical writing experience.
• Immunology therapeutic area experience is strongly preferred.
• Ability to interpret, summarize, and present statistical and medical information accurately.
• Compound lead and/or submission lead experience is preferred.
• Proficiency in written and spoken English is essential.
• Strong leadership, project management, and time management skills.
• Demonstrated learning agility and mentoring competency.
• Strong attention to detail.

Compensation and Benefits (United States)

The anticipated base pay range is $109,000 to $174,800. This position is eligible for an annual performance bonus. Employees may be eligible for comprehensive benefits including medical, dental, vision, life insurance, disability, retirement plans (pension/401k), and generous time off. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.