Lead preparation of clinical trial documents including protocol synopses, full protocols, and clinical study reports
Lead development of clinical and nonclinical documents submitted to regulatory authorities including investigator brochures, study protocols, model informed consents, interim and final CSRs, module 2 documents, and regulatory briefing books
Produce complex clinical or scientific documents and sections of INDs, NDAs, CTDs, and dossiers
Position information and data for presentation of clinical, pharmacokinetic, pharmacodynamic and statistical written materials; lead compilation of CSR appendices and clinical narratives
Provide detailed medical editing review (copy editing and content review) of draft and final documents
Ensure document content and style adheres to EMEA/FDA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines
Perform literature searches and reviews to obtain background information and provide literature references
Develop medical writing SOPs and style guidelines
Manage timelines for document preparation, create detailed processes, set up kick off and comment resolution meetings, and own workflows in Veeva
Perform other duties as assigned
Requirements
Bachelor’s degree or equivalent in a scientific discipline, advanced degree preferred
At least 7 years’ experience in regulatory writing and knowledge of preparing documents to ICH standards
Prior experience within the Pharmaceutical or CRO industry
Strong scientific and/or medical writing knowledge preferred
Ability to lead writing and compilation of clinical documents
Ability to influence and drive key decisions and stakeholders within a project team
Strong understanding of pharmaceutical industry procedures and regulations
Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance
Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Best-in-class benefits for our team of SpringWorkers (see Benefits page).
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