Medical Writer III, Regulatory Medical Writing, X-TA

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. Learn more at https://www.jnj.com

Job Function

Medical Affairs Group

Job Sub Function

Medical Writing

Job Category

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

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; or Beerse, Belgium. 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):

United Kingdom -Requisition Number: R-049117

Belgium/Netherlands/France/Germany - Requisition Number: R-052260

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Are you ready to join our team? Then please read further!

You Will Be Responsible For

• 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 (eg, with clinical team) 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. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas)
  
  

under supervision. Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical).

• Coach or mentor of more junior staff on document planning, processes, and content. Provides peer review as needed.
• Active participant in or lead of process working groups.
  
  

Qualifications / Requirements

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) prefered.
• At least 6 years of relevant pharmaceutical/scientific; 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.
• Able to function in a team environment.
• Strong project/time management skills.
• Strong project/process leadership skills.
• Able to resolve complex problems under
  
  

supervision.

• Demonstrate learning agility.
• Able to build solid and productive relationships with cross-functional team members.
  
  

Benefits

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.

Required Skills

Medical Writing, Process Leadership, Regulatory Writing

Preferred Skills

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)