Medical Writer II India Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. ??Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. ??Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. ??Perform literature searches/reviews as necessary to obtain background information and training for development of documents. ??Review statistical analysis plans and mock statistical output to determine appropriateness of content at for clinical writing.
Ensure that all work is complete and of high quality prior to team distribution or shipment to client. o Confirm data consistency and integrity across the document. o Prepare documents... for publishing readiness, when applicable. Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. o Provide suggested alternative content when contributors provide content that does not meet document needs. Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.Qualifications 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. Possesses team leadership skills and cross-cultural sensitivity. Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. Strives to understand and satisfy client needs. Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. 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. Bachelor's degree in Life Sciences/Health Related Sciences or equivalent India undefined undefined