Trainee Medical Writer

Trainee Medical Writer

Job Description:

• Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize low complexity documents, such as patient narratives, public disclosure documents, and simple aggregate safety reports (e.g., Periodic Adverse Drug Experience Report [PADERs]), under supervision of the project medical writer or other appropriate departmental supervision.
• With appropriate departmental supervision and mentoring, provide writing support for more complex clinical documents, such as informed consent forms (ICFs) and clinical study reports (CSRs)/CSR shells. This could involve writing certain sections or supporting the Lead Medical Writer on specific authoring tasks. Provide direction to Document Specialists for appendices compilation and related tasks, as required.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Ensure that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.

Job 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 steps 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.
• Strives to understand and satisfy client needs.
• Exhibits knowledge of regulatory documents and ICH-GCP guidelines.
• Scientific background essential; some experience of pharmaceutical industry and anunderstanding of clinical research are preferred.
• Knowledge or ability to learn software and systems: MS Office (Word proficiency required),document management systems, collaborative authoring (e.g., SharePoint), file conversion anddatabases (Excel).
• Fluent in written and spoken English with appropriate attention to phraseology, grammar, andpunctuation.

Master's degree or PhD in Life Sciences/Health Related Sciences or equivalent. Pass out year 2022 and 2023.

Location: Open in India