Lead Medical Writer

3M HEALTHCARE; Burlington; On-site; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Programme

Life assurance

Flexible benefits

Job summary

ICON plc is seeking a Lead Medical Writer to drive the preparation, editing, and review of clinical study documents with precision and clarity.

You will collaborate with cross‑functional teams, interpret trial data, and shape publication plans, abstracts, posters, and manuscripts for peer‑reviewed journals and conferences. Mentoring junior writers, you will foster excellence and scientific rigor across the medical writing group.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Proficiency in interpreting and summarizing complex clinical trial data, with excellent writing, editing, and proofreading skills.
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and experience interacting with regulatory agencies.
• Ability to work in a fast-paced, deadline-driven environment, manage multiple projects, and prioritize.
• Excellent interpersonal and communication skills to collaborate with cross-functional teams and influence stakeholders.

Responsibilities

• Lead the preparation, review, and editing of clinical study documents (CSRs, IBs, regulatory submissions) with accuracy and clarity.
• Collaborate with cross-functional teams (clinical research, biostatistics, regulatory affairs, medical affairs) to interpret and summarize trial data.
• Participate in planning and execution of clinical development programs, providing scientific input and design considerations.
• Contribute to publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and conferences.
• Mentor and coach junior medical writers to foster excellence and continuous learning within the team.

Skills

Medical writing

Editing

Regulatory knowledge

Interpersonal skills

Project management

Education

Bachelor's degree

Job description

Lead Medical Writer

ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Do

• Lead the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy and clarity.
• Collaborate closely with cross‑functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data and summarize scientific findings.
• Participate in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
• Contribute to the development of publication plans, abstracts, posters, and manuscripts for submission to peer‑reviewed journals and presentation at scientific conferences.
• Mentor and coach junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

Your Profile

You will have a strong foundation in medical writing, with the experience to work independently and guide others.

Required qualifications and experience

• Bachelor's degree in a relevant scientific discipline or healthcare‑related field.
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills.
• Strong understanding of regulatory requirements (e.g., ICH‑GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.
• Demonstrated ability to work effectively in a fast‑paced, deadline‑driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross‑functional teams, build relationships with key stakeholders, and influence decision‑making processes.

What ICON can offer you

• Competitive salary.
• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24‑hour access to a global network of over 80,000 independent specialised professionals who are there to support your well‑being.
• Life assurance.
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, and others.

We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.