Medical Writer II 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.

• eMedical Writer II will research, create, edit, and
• coordinate the production of clinical documents associated with submissions to regulatory authorities,
• including but not limited to: study protocols, model informed consents, interim and final clinical study reports,
• and safety update reports. The Medical Writer II will also be responsible for the production of clinical studies
• documentation associated with clinical trials that may not be included in a regulatory submission. The
• Medical Writer II may serve as the primary client contact.
• Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
• Extensive clinical/scientific writing skills.
• Scientific background essential; writing experience includes multiple clinical study reports.
• Advanced word processing skills, including MS Office (expertise 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 the non-English language, proficiency in the relevant language is a prerequisite.

Education

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