Medical Writer III, Medical Writing X-TA

Overview

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 Med Tech, 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.

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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

All Job Posting Locations:
Raritan, New Jersey;
Spring House, Pennsylvania

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for a Medical Writer III, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe, UK;
Leiden, Netherlands;
Neuss, Germany;
Paris, France;
Beerse, Belgium;
Spring House or Raritan, United States, or Allschwil, Switzerland. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): UK - Requisition R-049117;
Belgium/Netherlands/France/Germany - Requisition R-052260;
United States – Requisition R-059033;
Switzerland – Requisition R-059034. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional document planning and review meetings; interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices; establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team as needed.
• Functioning as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision; serving as the primary point of contact for medical writing activities for the cross-functional team (e.g., clinical).
• Coaching or mentoring more junior staff on document planning, processes, and content; providing peer review as needed.
• Active participation in or leadership of process working groups.

• A university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred.
• At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years of relevant medical writing experience is required.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• Attention to detail; ability to function in a team environment.
• Strong project/time management skills and strong project/process leadership skills.
• Able to resolve complex problems under supervision and demonstrate learning agility.
• Able…