Medical Writer II – Early Phase Clinical Research
Job Requisition ID: JR141822
Employment Type: Full-Time
Work Mode: Office or Home (Remote/Hybrid Options Available)
Location: Canada (Remote Eligible)
Posted: 4 Days Ago
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Medical Writer II to join its Early Phase Clinical Trials division. This role offers an opportunity to contribute directly to the development of innovative therapies by supporting clinical documentation, regulatory submissions, and scientific publications for early-stage clinical programs.
The Medical Writer II will work closely with cross-functional teams to deliver high-quality, compliant, and scientifically robust documents aligned with global regulatory standards.
Key Responsibilities
Prepare, write, review, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in accordance with internal standards and regulatory guidelines
Conduct scientific literature reviews, analyze and interpret clinical trial data, and support the development of manuscripts, abstracts, posters, and conference presentations
Support the review and validation of clinical data, ensuring accuracy, completeness, and alignment with study protocols, SOPs, and regulatory requirements
Participate in project meetings, teleconferences, and client interactions, contributing to discussions on timelines, deliverables, and document strategy
Stay current with emerging scientific trends, therapeutic area developments, and regulatory updates, applying best practices in medical writing to all deliverables
Required Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline
Experience:
Minimum 3 years of professional experience in medical writing within the pharmaceutical, biotechnology, or CRO industry
Experience supporting early-phase (Phase I/II) clinical trials is highly preferred
Skills & Competencies:
Strong command of scientific and medical terminology with excellent written and verbal communication skills
Proven ability to translate complex clinical data into clear, concise, and regulatory-compliant documents
Strong analytical and critical thinking skills, with experience in clinical data review and interpretation
Working knowledge of regulatory requirements, ICH guidelines, and publication standards
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Familiarity with document management systems, reference management tools, and basic statistical concepts is an advantage
Why Join ICON?
ICON is committed to fostering a culture of inclusion, innovation, and scientific excellence. Employees are empowered to grow professionally while contributing to research that improves patient outcomes worldwide.
Compensation & Benefits
ICON offers a competitive salary along with a comprehensive benefits package designed to support work–life balance, personal well-being, and long-term financial security, including:
Generous annual leave entitlements
Comprehensive health insurance options
Competitive retirement planning programs
Global Employee Assistance Programme (TELUS Health) with 24/7 professional support
Life assurance coverage
Flexible, country-specific optional benefits such as wellness programs, childcare support, gym discounts, and subsidized travel
Diversity, Equity & Inclusion
ICON is committed to providing an inclusive and accessible workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment, and reasonable accommodations are available throughout the recruitment process.
Application Guidance
Candidates who may not meet every listed requirement are encouraged to apply. ICON values potential, continuous learning, and a collaborative mindset, and this role may open pathways to broader opportunities within the organization.
Advance your medical writing career in early-phase clinical research with ICON. Apply now through thepharmadaily.com.
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