Medical Writer III, Oncology

7710-Janssen-Ortho Inc. (formerly Ortho-McNe Legal Entity; Toronto; Hybrid; CAD 87,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Medical Writer III, Regulatory Medical Writing to support Oncology within the Integrated Data Analytics & Reporting (IDAR) group. Hybrid work model with three onsite days weekly; Canada location in Toronto may be considered. Strong leadership in MW across compounds and submissions is required.

Responsibilities include drafting and coordinating CSR/IB/documents, leading cross-functional reviews, and mentoring junior staff while ensuring quality under supervision.

Qualifications

• University/college degree in a scientific discipline is required.
• An advanced degree (Masters/PhD/MD) is preferred.
• Oncology experience is preferred.

Responsibilities

• Write or coordinate clinical and regulatory documents (CSRs, IBs, protocols, summaries, RMPs, responses, briefing documents).
• Lead cross‑functional document planning and review meetings.
• Interact with cross‑functional colleagues on document content and champion MW processes.
• Establish document timelines and strategies within internal processes, with mentorship as needed.
• Complete time reporting, training, metrics databases, and project tracking in company systems.
• Lead as a writer on most compounds or submissions under supervision.
• Serve as primary MW contact for the cross-functional team.
• Coach or mentor junior staff on document planning, processes, and content.
• Provide peer review as needed.

Skills

Regulatory writing leadership

Cross-functional collaboration

English technical writing

Education

Bachelor's degree in scientific discipline

Advanced degree preferred

Job description

Company 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 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 jnj.com 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.

Position Overview

We are searching for the best talent for Medical Writer III, 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. 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: R-105516 Belgium/Netherlands: R-105590 United States: R-105615 Canada: R-105619.

Purpose

Able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs. Leads in a team environment and matrix. Able to function as a lead MW on most compounds, under supervision. Actively participates in or leads process working groups. Provides input into functional tactics/strategy (eg, writing teams, process working groups). Highly proficient in the use of internal systems, tools, and processes.

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 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.
• Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coaching or mentoring more junior staff on document planning, processes, and content.
• Provides peer review as needed.
• Actively participating in or leads process working groups.

Principal Relationships

Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.

External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

Education and Experience Requirements

A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience! Oncology therapeutic area experience is preferred. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision. Compound lead and/or submission lead experience is preferred. Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine. Able to build solid and positive relationships with cross-functional team members. Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision. Able to resolve complex problems under supervision. Demonstrate learning agility (self-development) and mentoring competency (development of others). Strong attention to detail. Builds solid and productive relationships with cross-functional team members.

Benefits

Benefits The expected base pay range for this position is $87,000 to $140,300 CAD.

The Company uses Artificial Intelligence in its assessment of applicants.

This job posting is for an existing position.

Ineligibility for severance.

Accessibility for Ontarians with Disabilities Act.

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.

The anticipated base pay range for this position is : $87,000.00 - $140,300.00

Additional Description for Pay Transparency: For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Why Join Us

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/.