Medical Writer II, Oncology

7710-Janssen-Ortho Inc. (formerly Ortho-McNe Legal Entity

Toronto

Hybrid

CAD 74,000 - 120,000

Full time

8 days ago

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Job summary

Johnson & Johnson in Canada seeks a Medical Writer II, Regulatory Medical Writing – Oncology, integrated data analytics & reporting. You will support our Oncology regulatory documents within the Regulatory Medical Writing team, authoring diverse writing outputs.

This role develops within a team environment, requiring collaboration across functions, meeting timelines, and mentoring junior staff. Hybrid work with onsite days and case-by-case remote options are available.

Qualifications

Minimum Bachelor’s in a scientific field.
2+ years pharma/regulatory writing experience.
2–4+ years regulatory medical writing.
Strong English writing and communication skills.

Responsibilities

Write and coordinate basic clinical documents (Phase1/2 CSRs, protocols, IBs).
Contribute to and coordinate low to medium complexity documents (Phase2/3 CSRs, protocols, updates).
Perform document QC, literature searches, and references as needed.
Participate in cross-functional document planning and review meetings.
Mentor junior staff on planning, processes, and content.

Skills

Regulatory writing

Medical writing

Cross-functional collaboration

Project coordination

English writing

Education

University/college degree in scientific discipline

Advanced degree preferred (Master’s/PhD/MD)

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.

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.

Learn more at https://www.jnj.com

Position

Medical Writer II, Regulatory Medical Writing – Oncology; Integrated Data Analytics & Reporting (IDAR)

Job Function: Medical Affairs Group | Job Sub Function: Medical Writing | Job Category: Professional

Locations and Work Arrangement

Possible locations: Beerse, Belgium; Leiden, The Netherlands; High Wycombe/Maidenhead, UK; Toronto, Canada; Spring House / Titusville, United States.

Hybrid – 3 days onsite per week. Remote work options may be considered on a case‑by‑case basis and if approved by the company.

Job Summary

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

Purpose

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.

Responsibilities

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, 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 championing 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, cross‑functional meetings (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 providing peer review.

Qualifications and 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).

Required Skills