Enecia Rivera Email and Phone Number

•Author, edit, review, and compile Clinical Study Reports, Narratives, IBs, Clinical Study Protocols, and Appendices documents while adhering to ICH, GCP and FDA guidelines•Manage medical writing activities while adhering to agree upon timelines •Perform quality reviews on regulatory and clinical documents within strict deadlines•Coordinate the development of clinical study reports, protocols, and document updates •Assist in the development of departmental guidance documents and templates•Understands global health authority requirements (FDA, EMA, and CFDA/NMPA)•Coordinate and exchange information on requested documents and timelines and demonstrate the standard processes to perform required tasks

• Author, edit, review, and compile Clinical Study Reports, IBs, Clinical Study Protocols, Clinical Evaluations, Appendices, Common Technical Documents, IND, NDA, and EMA documents while adhering to ICH, GCP and FDA guidelines• Interpret and summarize data from clinical studies to prepare, author, and review shell reports• Manage medical writing activities by developing agreed upon timelines, delegating QC reviews, and identifying contributing authors • Involved in end-to-end activities for NDA/IND submissions• Perform quality reviews on regulatory and clinical documents within strict deadlines• Created platforms to aid in version control of documents• Develop templates for CSRs, Protocols, CSR and Protocol Synopsis, IBs, and appendices for efficiency• Create departmental style guides for document harmonization• Develop departmental SOPs• Ensure all documents were compliant with guidelines, templates, and SOPs• Understand and translate data from multiple sources• Represent the medical writing sector and contribute to departmental and project team meetings• Coordinate and exchange information on requested documents and timelines and demonstrate the standard processes to perform required tasks

• Author, copy edit, proofread and fact-check regulatory and clinical documents for FDA submissions • Ensure all documents are consistent with correct style, punctuation, and grammar using AMA style and document style guides• Author, review and edit SharePoint websites, documents, videos, training modules, informational slide decks, and instructional workshops• Work closely with Medical Writers to maintain a clear understanding of assignments, and ensure projects are completed within strict timelines while following editing processes• Create, edit and review reference annotations for accuracy and efficient navigation• Employ and strategically communicate the level of editing a project requires and ensure QC process steps are completed on every project• Develop links and annotations within documents in online submission systems• Understand and translate data from multiple sources

• Author, copy edit, review, fact-check, and implement changes to work instructions and SOPs to ensure documents adhere to FDA and GXP regulations within strict deadlines• Perform quality assessments on all documentation before submission to the FDA• Ensure correct style, punctuation, grammar, and consistency using AMA style• Work closely across sites with executive management, writers, and regulatory personnel to communicate project timelines and QC processes• Provides editorial reviews for company development documents and plans• Consistent in the managing and prioritizing multiple projects while adhering to strict company deadlines• Create annotations and links on documents for accuracy and efficient navigation throughout each document• Facilitate strong communication, collaboration on all projects and change controls