- Gather, review, analyse, and evaluate pertinent resources to prepare, develop, and finalise clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports,
- Common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
- 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/format for clinical writing.