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Analyst II, Medical Writing - Job Opportunity at Johnson & Johnson

Toronto, Canada
Full-time
Mid-level
Posted: June 17, 2025
Remote
CAD 80,000-128,800 per year

Benefits

Comprehensive healthcare innovation exposure through work on breakthrough treatments and medical technologies
Remote work flexibility enabling optimal work-life balance and eliminating commute constraints
Access to cutting-edge pharmaceutical research and development projects spanning early to late-stage clinical trials
Professional development opportunities through mentorship programs and cross-functional collaboration
International career mobility with role availability across multiple countries including US, Switzerland, Belgium, and UK

Key Responsibilities

Drive strategic clinical document development including Phase 1-3 protocols, Clinical Study Reports, and Investigator Brochures that directly impact drug approval timelines and patient access to life-saving treatments
Lead cross-functional document planning and review meetings to ensure seamless collaboration between regulatory, clinical, and medical affairs teams, maximizing project efficiency and compliance
Establish critical document timelines and regulatory strategies that determine the success of multi-million dollar clinical programs and market entry timing
Champion medical writing best practices across therapeutic areas, elevating organizational standards and reducing regulatory review cycles
Mentor junior staff and guide cross-functional teams on complex regulatory processes, building institutional knowledge and team capabilities
Manage document quality control processes that ensure regulatory compliance and reduce risk of costly submission delays or rejections

Requirements

Education

A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

Experience

A minimum of 2 years of relevant pharmaceutical/scientific experience is required. A minimum of 0 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.

Required Skills

Strong oral and written communication skills Attention to detail Ability to function in a team environment Organizes time well Demonstrates learning agility Builds solid and productive relationships with cross-functional team members Gains experience in interpreting, summarizing, and presenting statistical and medical information Emerging leadership skills in project and process management Develops and applies knowledge of regulatory guidance documents such as ICH requirements
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in personalized medicine and precision therapeutics, creating increased demand for medical writers who can effectively communicate complex biomarker and genomic data to regulatory authorities. This trend is driving the need for writers with stronger statistical interpretation skills and experience with novel trial designs. Regulatory harmonization efforts across global markets are intensifying the need for medical writers who understand ICH guidelines and can develop documents that meet multiple regulatory requirements simultaneously, reducing development timelines and costs for pharmaceutical companies. The rise of digital health technologies and real-world evidence is transforming clinical documentation requirements, with medical writers now expected to incorporate digital endpoints, wearable device data, and patient-reported outcomes into traditional regulatory submissions.

Salary Evaluation

The provided salary range of CAD 80,000-128,800 is competitive for the Toronto market and aligns well with mid-level medical writing positions at major pharmaceutical companies. This range reflects the premium that established companies like Johnson & Johnson pay for regulatory writing expertise, positioning in the 70th-85th percentile for similar roles in the Canadian market.

Role Significance

Typically manages small project teams of 3-5 cross-functional members while collaborating within larger medical writing departments of 15-25 professionals, with direct mentoring responsibilities for 1-2 junior writers and regular interaction with clinical, regulatory, and statistical teams.
This Analyst II position represents a mid-level role with significant autonomy and leadership responsibilities, positioned above entry-level writers but below senior management. The role involves independent project leadership while maintaining supervisory support for complex initiatives, indicating substantial trust and responsibility within the organization.

Key Projects

Leading clinical study report development for Phase II/III trials with patient populations ranging from 200-3000 participants, directly impacting regulatory submission timelines and market approval decisions Managing regulatory response strategies for FDA, Health Canada, and EMA queries that can determine the success or failure of multi-million dollar development programs Coordinating investigator brochure updates that ensure global investigator safety and compliance across international clinical trial networks

Success Factors

Mastery of regulatory writing standards and ICH guidelines, as pharmaceutical companies face increasing scrutiny from global regulatory bodies and any documentation deficiencies can result in costly delays or rejections that impact market competitiveness and patient access to treatments. Advanced project management capabilities combined with cross-functional leadership skills, as modern drug development requires seamless coordination between diverse teams operating under aggressive timelines where communication breakdowns can derail entire development programs. Statistical interpretation expertise and ability to translate complex clinical data into compelling regulatory narratives, as the success of drug approvals increasingly depends on clear presentation of efficacy and safety data to regulatory reviewers who evaluate hundreds of submissions annually.

Market Demand

High demand driven by increasing clinical trial complexity, accelerated drug development timelines post-COVID, and the growing emphasis on regulatory compliance across global markets, with medical writers being essential for maintaining competitive advantage in drug approvals.

Important Skills

Critical Skills

Regulatory writing expertise following ICH guidelines is absolutely essential as pharmaceutical companies face increasing global regulatory complexity, and any documentation deficiencies can result in multi-million dollar delays or program failures that impact both company performance and patient access to life-saving treatments. Cross-functional collaboration and communication skills are paramount in modern drug development environments where seamless coordination between clinical, regulatory, statistical, and medical affairs teams determines program success, and medical writers often serve as the central communication hub for complex projects. Statistical interpretation and data presentation abilities are crucial as regulatory approval decisions increasingly depend on clear, compelling presentation of clinical trial results, and medical writers must translate complex statistical analyses into narratives that regulatory reviewers can quickly understand and evaluate.

Beneficial Skills

Advanced therapeutic area knowledge in high-growth sectors like oncology, rare diseases, or cell and gene therapy, as these areas command premium compensation and offer accelerated career advancement opportunities due to their strategic importance and complexity. Digital health and real-world evidence expertise as the industry increasingly incorporates novel data sources and endpoints into regulatory submissions, creating competitive advantages for professionals who can navigate these emerging requirements effectively.

Unique Aspects

Multi-country role availability provides exceptional international mobility and career flexibility, allowing professionals to gain diverse regulatory experience across different healthcare systems and cultural contexts while maintaining employment continuity within the same organization.
Direct involvement in breakthrough therapy development across J&J's innovative medicine portfolio, offering exposure to cutting-edge treatments for complex diseases that represent the forefront of medical innovation and have potential to transform patient outcomes globally.
Comprehensive mentorship and professional development framework that combines formal training programs with hands-on experience across multiple therapeutic areas, accelerating career growth and expertise development in ways that smaller organizations cannot match.

Career Growth

Progression to senior-level positions typically occurs within 2-3 years with strong performance, while management roles generally require 4-5 years of demonstrated leadership and strategic thinking capabilities in medical writing environments.

Potential Next Roles

Senior Medical Writer positions with expanded therapeutic area oversight and regulatory strategy responsibilities, typically involving leadership of multiple concurrent programs and direct client interaction Medical Writing Manager roles focusing on team leadership, process optimization, and departmental strategy development within pharmaceutical or consulting organizations Regulatory Affairs Associate Director positions leveraging medical writing expertise to drive broader regulatory strategy and agency interaction responsibilities

Company Overview

Johnson & Johnson

Johnson & Johnson operates as the world's largest and most diversified healthcare company, with a pharmaceutical division that consistently ranks among the top three globally by revenue. The company's innovative medicine portfolio spans multiple therapeutic areas including oncology, immunology, neuroscience, and infectious diseases, with a robust pipeline of breakthrough therapies that require extensive regulatory documentation support.

J&J maintains dominant market positions across multiple healthcare sectors with annual revenues exceeding $100 billion, representing a stable and prestigious employer that offers exceptional career development opportunities and exposure to cutting-edge medical innovations that shape global healthcare standards.
The Toronto office serves as a key hub for J&J's Canadian operations and supports broader North American regulatory strategies, providing medical writers with exposure to both domestic Health Canada requirements and international regulatory harmonization initiatives across the company's global development portfolio.
J&J fosters a collaborative, science-driven culture that emphasizes patient-centricity and innovation, with strong commitments to employee development, diversity and inclusion, and work-life balance that make it consistently rank among the top pharmaceutical employers globally.
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