• Coordinate, author and publish submission ready, high quality clinical protocols, amendments, administrative letters, clinical study reports, safety narratives, statistical analysis plans, and other documents using document management system• Exercise good documentation principles (organization, clarity, scientific standards)• Quality review and edit documents• Support internal and external audits• Develop continuous training slides and train colleagues in document management system usage• Lead and collaborate with team members to resolve issues, errors, or inconsistencies with various document• Support the development and submission of risk evaluation and mitigation strategy (REMS) for products

• Authored, quality control (QC) reviewed, and made electronic publish-ready responses to external and internal safety inquiries for products, including written responses to inquiries from health authorities• Summarized literature and safety database results including authoring narrative summaries• Coordinated, analyzed, and integrated medical, scientific, and regulatory data from a variety of sources and functional groups to support responses to health authorities, various reports and/or presentations• Managed all assigned projects in support of numerous clinical trials and post marketing commitments while meeting regulatory timelines• Supported safety physicians by determining, describing, and monitoring the safety profiles of assigned investigational and marketed products (primarily oncology and immunology)• Worked with safety physicians to identify and validate all safety signals• Performed literature and safety database searches in support of aggregate reports • Led cross-functional medical safety surveillance teams (MSTs) including elevating key MST issues, signals, and milestones impacting MST activities and supported RMPs, PBRERs, PSURs, etc.

• Managed all assigned projects in support of numerous clinical trials (phase I-III)• Handled all stages of serious adverse event (SAE) processing for oncology products including triaging SAE reports, coding events, performing data entry, writing and editing case narratives, and QC reviewing cases prior to submission• Performed clinical data collection and reconciliation • Led cross-functional medical surveillance/safety team and communicated issues impacting the safety activities including documents and product milestones• Supported safety physicians by determining, describing, and monitoring the safety profiles of oncology products• Participated in the development of pharmacovigilance agreements (PVAs) with multiple vendors

• Managed, authored, QC reviewed, and submitted to health authorities suspected unexpected serious adverse reactions (SUSARs) for oncology, immunology, virology, neuroscience, and cardiovascular products global products• Managed all assigned projects in support of numerous clinical trials (phases 1-4) and post marketing commitments • Supported safety physicians by determining, describing, and monitoring the safety profiles of assigned products including support of PSURs, RMPs, PBRERs, etc• Led and collaborated with cross functional teams on drug safety-related issues• Performed data collection and reconciliation including tracking of clinical specimen and imaging data• Applied sound analytical thinking and database query skills to gather, review, summarize and evaluate complex clinical data in a timely manner • Performed safety database searches in support of safety reports • Managed outsourced resources/vendors for various safety activities• Initiated and collaborated with programmers to develop new clinical database patient profiles and trained safety reporting team• Developed SOPs for SAE processing and trained physicians, scientists, safety associates, and vendor partners• Supported internal and external audits

• Designed, implemented, conducted, and managed preclinical studies• Performed data management for preclinical studies• Contributed to 9 scientific publications

• Participated in all aspects of clinical trials from study start-up to final clinical study report for oncology, immunology, virology, neuroscience, and cardiovascular products• Evaluated new clinical sites for studies, coordinated and maintained effective communications with clinical investigators, study coordinators, and other clinical study personnel• Established milestones for clinical studies and ensured that study milestones were successfully achieved• Managed clinical study start-up and study close-out activities• Attended and supported Investigator Meetings• Conducted recall activities including communications with investigators• Prepared training slides and posters in support of clinical studies• Evaluated new clinical protocol applications as member of Protocol Review Committees