Medical Writer II, Oncology

7710-Janssen-Ortho Inc. (formerly Ortho-McNe Legal Entity; Toronto; Hybrid; CAD 74,000 - 120,000; Full time

Benefits offered by this job

Base pay CAD 74k–119.6k per year

AI-based applicant assessment

Disability accessibility

Job summary

Johnson & Johnson is seeking a Medical Writer II for Regulatory Medical Writing in Oncology. The role is hybrid with some onsite requirements in Toronto, Canada.

You will craft and coordinate clinical/regulatory documents, ensuring accuracy and compliance while collaborating with cross‑functional teams. The ideal candidate has 2+ years of regulatory medical writing experience, strong English communication, and the ability to summarize complex data.

Qualifications

• University/college degree in a scientific discipline is required.
• Advanced degree (Master’s/PhD/MD) preferred.
• 2+ years of pharma/regulatory medical writing experience required.
• Strong written and verbal English communication is essential.
• Ability to interpret, summarize scientific/medical data and work in cross-functional teams.

Responsibilities

• Write and coordinate basic to mid-complexity regulatory documents (Phase I–III CSRs, protocols, summaries).
• Perform document QC, manage abbreviations, references, and literature searches.
• Lead or participate in cross-functional document planning and review meetings.
• Maintain timelines, schedule, and project tracking with mentorship as needed.
• Mentor junior writers and contribute to process improvements.

Skills

Communication skills

English proficiency

Team collaboration

Problem solving

Education

Bachelor’s degree in scientific discipline

Master’s/PhD/MD preferred

Tools

Microsoft Word

Excel

PowerPoint

Outlook

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 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.

Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Toronto, Ontario, Canada

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 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.

Responsibilities

• 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, completing list of abbreviations or references, conducting literature searches, and performing 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.

Qualifications / Requirements

• 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, interpret, and summarize scientific or medical data.
• Ability to function in a team environment and to build solid and positive relationships with cross‑functional team members.
• Demonstrated problem‑solving skills.
• Strong attention to detail.
• Strong time management and project/process management skills.
• Demonstrated learning agility / gains experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision.
• Emerging leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
• Resolves basic problems independently and more complex problems with supervision.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirements.
• Sound knowledge of Microsoft Office programs (eg, Microsoft Word, Excel, PowerPoint, Outlook).

Benefits

• The expected base pay range for this position is $74,000 to $119,600 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.
• The anticipated base pay range for this position is : 74,000 - 119,600 CAD

Required and Preferred Skills

• Business Behavior
• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaboration
• Copy Editing
• Data Gathering and Analysis
• Data Savvy
• Document Management
• Industry Analysis
• Medical Affairs
• Medical Communications
• Problem Solving
• Process Oriented
• Proofreading
• Quality Standards
• Research Ethics

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.