Serves as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects.
•Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
•Develops or supports, a variety of documents that include but not limited to:
-Clinical study protocols and clinical study protocol amendments;
-Clinical study reports;
•Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required.
•Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
•Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
•Performs on-line clinical literature searches, as applicable.
•Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
•Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
•Completes required administrated tasks within the specified timeframes.
•Performs other work-related duties as assigned. Minimal travel may be required (less
•Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
•Extensive knowledge of English grammar with a familiarity with AMA style guide.
•Understanding of FDA and ICH regulations and guidelines strongly preferred.
•Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach.
•Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
•Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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