Senior Medical Writer - FSP

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP has an exciting opportunity for a Medical Writer ! 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: 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