Medical Writer III, X-TA

7360-Janssen-Cilag Limited Legal Entity; High Wycombe; Hybrid; GBP 65,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Flexible working environment

Career development opportunities

Job summary

Johnson & Johnson is seeking a Medical Writer III, Regulatory Medical Writing to support multiple therapeutic areas within IDAR. The role offers hybrid work (3 days onsite weekly) across locations in the UK and beyond, with case-by-case remote options.

Focused on regulatory documentation and cross-functional leadership, the position invites experienced writers to advance quality and compliance. Candidates should have a science degree, 6+ years in pharma, and 4+ years in medical writing, with

Qualifications

• A university/college degree in a scientific discipline is required.
• An advanced degree (eg, Masters, PhD, MD) preferred.
• At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years in medical writing.
• Excellent oral and written communication skills for cross-functional discussions.
• English fluency required.
• Attention to detail and teamwork skills are essential.
• Strong project/time management and leadership abilities.
• Ability to resolve complex problems under supervision and show learning agility.
• Ability to build solid cross-functional relationships.

Responsibilities

• Write or coordinate regulatory documents such as CSRs, IBs, protocols, and briefing documents.
• Lead cross-functional document planning and review meetings.
• Interact with colleagues on document content and promote medical writing best practices.
• Establish document timelines and strategies with mentorship as needed.
• Serve as lead writer on compounds/submissions under supervision.
• Be the primary contact for medical writing activities within the cross-functional team.
• Coach junior staff on planning, processes, and content.
• Provide peer review as needed.
• Participate in or lead process working groups.

Skills

Medical Writing

Regulatory Writing

Project Management

Education

Bachelor's degree in a scientific discipline

Advanced degree (Masters/PhD/MD) preferred

Job description

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/innovative-medicine

Job Function: Medical Affairs Group
Job Sub Function: Medical Writing
Job Category: Professional
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

Job Description

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 Maidenhead, 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-103733 Belgium/Netherlands/France/Germany - Requisition Number: R-104917 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Responsibilities

• 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) preferred.
• 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 organization.

Required Skills

Medical Writing, Project Management, Regulatory Writing

Preferred Skills

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, Standard Operating Procedure (SOP)

Johnson & Johnson Family of Companies are equal opportunity employers, and 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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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/.