Simone Otto Email & Phone Number

Raleigh, North Carolina, Us

Supervise Medical Writers and provide general assistance to the medical writing team. Organize and maintain the medical writing work schedule. Assign suitably experienced Medical Writers to projects. Conduct performance reviews and discussions with Medical Writing Team. Communicate capacity with Client and discuss client needs. Continue to perform as a lead medical writer; leading global teams in the development of regulatory and safety documents necessary in the development of pharmaceuticals and devices.

Raleigh, North Carolina, Us

Lead teams in creation of multiple documents at major pharmaceutical company.Mentored new members, providing guidance, read-behinds, QC of documentsDeveloped, helped develop, or edited multiple documents, including but not limited to: Protocols (V1, Amendments, Synopses, Basket; Phase I - PASS, global and country specific, single arm - basket), NIS protocols, Real-world protocolsICFs (including pre-screening, mobile nursing, pregnant partner, COVID, Assents), briefing packages (including FDA, EMA, CDE) Investigator's Brochures Summary Documents (2.5 CO, 2.7 SBP, SCP, SCE, SCS, 2.7.5, 2.7.6)Response to QuestionsData SummariesClinical Study ReportsRWD journal articlesaCOsSmPCRMPSensitivity AnalysisFiling leadSAPPIPCEP/CER

 Managed multidisciplinary teams to produce high-quality deliverables according to client timelines Served as the point-of-contact for client interactions Led project kickoff and progress report meetings with clients Researched, tabulated, analyzed, and summarized nonclinical and clinical efficacy and safety data to support drug development and regulatory approval efforts  Participated in Type B meetings and submission of Sponsor meeting minutes; interpretation of WROs and submission of Clarifying Questions Wrote and edited sections of investigational new drug (IND) applications (Modules 1 and 2); wrote and edited IRs and updates to INDs Wrote and edited Pre-IND request letters, Pre-IND meeting packages, Type C meeting packages, and Investigator’s Brochures Researched and prepared drug development feasibility and regulatory strategy reports for clients Provided QC review for INDs, CSRs and other documents as requested Participated in Commercial Assessments

Research Triangle Park, Nc, Us

• Independent health science research in neuroscience project focused on the impact of cholinergic innervation on neural stem cell populations and adult neurogenesis in the dentate gyrus, and resultant implications for learning and memory. Also conducted a side project investigating the potential of Zika Virus as an infective neural agent capable of killing neural stem cells.• Maintained comprehensive and up-to-date knowledge, developed protocols and standard operating procedures, objectively assessed criteria, critically evaluated data, documented findings, interpreted results, wrote scientific abstracts and manuscript, supervised summer interns• Utilized scientific knowledge and expertise to perform a variety of management functions associated with the scientific peer review and research training support activities• Performed PubMed literature searches and assessed novel advancements related to multiple long-term projects• Responsible for significant aspects of laboratory/research unit including creation of ASPs, ordering equipment and materials, communication with potential collaborators, management of shared cryostat• Health research program administration experience in managing all aspects of my research projects and summer interns• Spearheaded acquisition of an LSM multiphoton microscope with piezo motorized stage and specialized lenses for visualizing cleared tissue• Provided policy direction and coordination for the planning and execution of initial neurobehavioral core, including participation in hiring of a core manager; pioneered use of delayed-non-matching to place task• Pioneered use of Imaris, a complex 3D imaging analysis software packages, in the Imaging Core • Acquired an understanding of the history, interests, internal dynamics, and relationships of NIEHS, a part of NIH• Used Microsoft Office software, Adobe Illustrator, Image J, Imaris, Ethovision, SPSS, and Graphpad Prism in the course of research

Durham, North Carolina, Us

Through copy-editing scholarly manuscripts originally written by non-native English speakers, I discovered my need to improve communication goes beyond improving language.

Doctor Of Philosophy (Ph.D.), Neuroscience

Bachelor Of Science - Bs, Molecular Biology

Associate Of Arts And Sciences - Aas, Fashion/Apparel Design

Anthropology