1000284535 ONTARIO LTD is a full-service corporation providing a broad range of expertise-based scientific

and clinical research and development services to worldwide pharmaceutical, biotechnology, and medical
device industries. We serve CROs and work with many of the most advanced drugs, biologics, and medical
devices in development today.
To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and
customer-focused individual to join our winning team as a Medical Writer II for our Oakville, Ontario,
Canada office, or remotely from a home-based office in the east coast of Canada.
Key accountabilities:
• Work closely with the Medical Writer team to achieve project milestones according to the project
timeline.
• Prepare clinical documents and scientific publications. This includes, but is not limited to, the
following: clinical study reports, clinical study protocols, investigator brochures, pharmacokinetic
reports.
• Perform internal QC procedures for clinical documents developed by other Medical Writers, such
as clinical study reports, clinical study protocols, investigator brochures, pharmacokinetic reports,
integrated efficacy or safety summaries, patient narratives, and manuscripts.
• Perform literature searches.
• Perform document e-publishing for clinical and regulatory documents.
• Plan and manage deliverables and timelines in accordance with clinical trial project teams’
requirements.
• Keep current with the general requirements or guidelines issued by the pharmaceutical drug trial
regulators and ICH.
Qualifications and experience:
• PhD in Life or Health Sciences.
• At least 18 months of experience in scientific and medical writing, with experience in the
pharmaceutical clinical trial environment.
• Experience in multiple therapeutic areas and Phase I through IV clinical trials.
• Experience with and understanding of GCP/ICH guidelines, including E3 Structure and Content of
Clinical Study Reports.
• Experience with writing research articles and grants.
• Ability to work well in multi-disciplinary teams, exhibiting the confidence to guide decision-making
for the document content strategy.
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
• Demonstrated ability to communicate effectively, orally and in writing.
• Detail-oriented and quality-focused.
• Well organized and able to work independently.
• Comprehensive skills in MS Office applications and Adobe Acrobat. Computing skills with R is
considered an asset.
• Hebrew speaker is considered an asset, as the majority of clients are based in Israel.
Additional information:
Status: Full time
Pay Scale: $55,000 to $65,000. Commensurate with education and experience
Work Shift: Monday to Friday, 8:30 a.m. to 4:30 p.m., available after regular business hours, if required.
Work Site: Remote
We thank all interested applicants; however, only those selected for an interview will be contacted.
1000284535 ONTARIO LTD is committed to upholding the principles of dignity, independence, integration,
and equal opportunity. We welcome and encourage applications from people with disabilities, and upon
request we will provide accommodations for candidates participating in any part of our recruitment and
selection process.