Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.
In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems,
you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.
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We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Opportunity to learn and grow through a performance and development goal-setting program.
Love where you work, and work where you love.
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Home Based, Canada
Under departmental supervision, the Medical Writer I will research, create, edit, and coordinate the production of clinical documents, including model informed consents, interim and final clinical study reports, and safety update reports. The Medical Writer I may provide writing support for more complex clinical documentation, with appropriate departmental supervision. The Medical Writer I may serve as primary contact with clients under appropriate departmental supervision.
Excellent interpersonal, verbal, and written communication skills.
Ability to consistently produce documents of high quality.
Demonstrates attention to details and proactivity.
Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members.
Strives to understand and satisfy client needs.
Knowledge and Experience:
Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
Good clinical/scientific writing skills.
Scientific background essential; writing experience of regulatory documents such as patient narratives, informed consent forms or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.
Good word processing skills, including MS Office (proficiency in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.