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Key Accountabilities:
Author Clinical Documents
Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to 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.Under appropriate departmental supervision as needed, review statistical analysis plans and mock statistical output to determine appropriatene...