Medical Writer II, Oncology

About the company

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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Job Function: Medical Affairs Group
Job Sub Function: Medical Writing
Job Category: Professional
Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
Location options: Beerse, Belgium;
Leiden, The Netherlands;
High Wycombe/Maidenhead, UK;
Toronto, Canada or Spring House / Titusville, United States.
Hybrid: 3 days onsite weekly. Remote work options may be considered on a case‑by‑case basis and if approved by the company.

• Writing and coordinating basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writing, contributing to, and/or coordinating low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performing document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participating in and may be leading cross‑functional document planning and review meetings.
• Working in a team environment with some guidance while increasing independence for longer‑term activities.
• Taking an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacting with cross‑functional colleagues on document content and champions MW 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.
• Guiding or training cross‑functional team members on processes and best practices.
• Leading early- or late‑stage compound writing teams with supervision, as required.
• Learning and adhering to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meeting with manager and mentors and attending departmental meetings.
• Attending cross‑functional meetings as appropriate (eg, project kick‑off and review meetings, study team meetings, Global Program Team meetings).
• Completing all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintaining and applying knowledge of industry, company, and regulatory guidelines.
• Mentoring more junior staff on document planning, processes, content, or provide peer review.

Principal Relationships: Internal manager, other writers, cross‑functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the planning and preparation of clinical documents.
External: May interact with or oversee the day‑to‑day work of contractors or external service providers as needed under close supervision. May collaborate with external partner company staff on codeveloped compounds.

A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, Master’s degree, PhD, MD) preferred. At least 2 years of relevant pharmaceutical/scientific experience is required. A range of 2 to 4+ years of regulatory medical writing experience is required. Strong oral and written communication skills in English. Ability to understand,…