Job title: Medical Writer II

Company: Parexel

Job description: e Medical 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 clin

e Medical 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 study 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.Qualifications . 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 non-English language, proficiency in relevant language is a prerequisite. Education: . Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.

Expected salary:

Location: India

Job date: Sun, 20 Feb 2022 23:27:07 GMT

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