Medical Writer I null

Job Description

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. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.

• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently produce documents of high quality.
• Demonstrates attention to detail and proactivity.
• Ability to understand all necessary steps in a project, plan, and identify critical paths.
• A flexible attitude concerning work assignments and new learning; readily adapts to changes.
• Ability to efficiently manage time spent on tasks and proactively identify a 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 the roles of other project team members.
• Strives to understand and satisfy client needs.
• 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 a non-English language, proficiency in the relevant language is a prerequisite.

Education

• Bachelor's degree in Life Sciences/Health-Related Sciences or equivalent.