Medical Writer II, Oncology

Job Function

Medical Affairs Group

Medical Writing

Professional

Toronto, Ontario, Canada

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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.

Learn more at

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.

We are searching for the best talent for Medical Writer II, Regulatory Medical Writing to support Oncology within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located Beerse, Belgium;
Leiden,The Netherlands;
High Wycombe/Maidenhead, UK;
Toronto, Canada or Spring House / Titusville, United States. 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.

As Medical Writer II, Regulatory Medical Writing, you will support our Oncology therapeutic area within our Regulatory Medical Writing team, to author diverse regulatory medical writing documents.

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-096079
• Belgium, Netherlands – Requisition Number: R-097258
• United States – Requisition Number: R-097262
• Canada – Requisition Number: R-097266

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

Develops within the medical writing role within the pharmaceutical industry.

Works in a team environment and matrix.

Performs routine tasks per established procedures.

Gains knowledge and applies internal standards, regulatory, and publishing guidelines.

With increasing skill, uses internal systems, tools, and processes.

Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level.

Functions as a lead writer on a project, indication, or a compound either early‑or late‑stage in life cycle under close supervision.

Participates in process working groups.

• Writing and coordinating basic clinical documents such as, but not limited to, Phase1 protocols, Phase1/2 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, Phase2/3 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.
• Leadi…