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| Job Location | Bangalore, Chennai, Hyderabad, Kolkata, Pune, Mumbai City, Delhi, Ahmedabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Operations Management / Process Analysis |
| EmploymentType | Full-time |
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 teammembers 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 obtainbackground information and training for development of documents. Review statistical analysis plans and mock statistical output todetermine appropriateness of content at for clinical writing.Ensure that all work is complete and of high quality prior to team distribution orshipment 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 orother appropriate regulatory guidelines, and comply with departmental,corporate or client SOPs and style guidelines, as applicable.o Provide suggested alternative content when contributors providecontent 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.QualificationsExcellent 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. Managemultiple 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, andunderstands roles of other project team members. Possesses team leadership skills andcross-cultural sensitivity. Ability to negotiate on behalf of medical writing to ensure resources, timelines andexpectations are aligned. Strives to understand and satisfy client needs. Gains trust and establish a connection with the client beyond ones project, to gainrepeat business and/or to widen existing scope and services.Demonstrated understanding of clinical research, the drug development process, and industryguidelines 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 systemsknowledge 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, andpunctuation. If required to perform translation work and quality control of documents written in non-Englishlanguage, proficiency in relevant language is a prerequisite.Bachelors degree in Life Sciences/Health Related Sciences or equivalent,
Keyskills :
clinical trialssafetyprotocolsresearchliteraturestatistical analysis plansstandard operating proceduresms officecopy editingstudy reportsspoken englishquality controlmedical writingword processingteam leadership