Experience

Omeros Corporation

• United States
• Biotechnology Research
• 100 - 200 Employee

• Manager, Regulatory Affairs

  • Jun 2023 - Present



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Associate Regulatory Affairs

  • Jun 2019 - Jun 2023

  United States Regulatory Lead/Manager (USRL) for Epogen® (epoetin alfa) and Aranesp® (darbepoetin alfa) US Regulatory Professional (USRP) for Aimovig® (erenumab aooe) , Evenity® (romosozumab aqqg) , Neupogen® (filgrastim), and Neulasta® (pegfilgrastim) -Engage and directly support Global and US Regulatory Lead (GRL; USRL) to conduct US regulatory activities/strategy for assigned products. -Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in… Show more United States Regulatory Lead/Manager (USRL) for Epogen® (epoetin alfa) and Aranesp® (darbepoetin alfa) US Regulatory Professional (USRP) for Aimovig® (erenumab aooe) , Evenity® (romosozumab aqqg) , Neupogen® (filgrastim), and Neulasta® (pegfilgrastim) -Engage and directly support Global and US Regulatory Lead (GRL; USRL) to conduct US regulatory activities/strategy for assigned products. -Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Leads. -Create and maintain product history documents within Amgen systems -Archive, summarize, and retrieve US regulatory documents and agency communications for designated projects -Review and contribute to Global Regulatory Strategic Plan -Perform regulatory intelligence research to support the development and content of the local and global regulatory strategy -Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies and internal SOPs -Assist the Global or Regional Regulatory Lead (RRL) by preparing supportive documentation (e.g., cover letters, RTQs) for regulatory deliverables -Coordinate global regulatory team (GRT) meetings in collaboration with GRL and RRL. -Support GRL or RRL in managing the process for responding to agency Requests for Information (RFIs), including development of the submission content plan within internal Regulatory Information Management (RIM) system. -Coordinate quality control (QC) of regulatory documentation (e.g., FDA meeting requests, briefing packages, and meeting minutes). -Provide primary authorship for routine regulatory correspondence. -Prepare regulatory packages and cross reference letters and complete regulatory forms to support agency communications -Interface across all supporting regulatory functions (e.g. labeling, regulatory writing, publishing, devices) acting as a central point of support for complex regulatory submissions. -Co-Chair for US Regulatory Forum (2021)

• Document Management Specialist (CW)

  • Feb 2019 - Jun 2019

  Process Document Management Lead within Quality, Compliance, Audit, Learning and Performance (QCA L&P) team. Ensured quality and compliance of controlled documents such as standard operating procedures (SOPs). -Primary role was to perform as a Process Document Management (PDM) Lead supporting Research & Development (R&D) Quality, Compliance & Audit, Learning and Performance (QCA L&P) function. -Developed project plans to address business need for a process document… Show more Process Document Management Lead within Quality, Compliance, Audit, Learning and Performance (QCA L&P) team. Ensured quality and compliance of controlled documents such as standard operating procedures (SOPs). -Primary role was to perform as a Process Document Management (PDM) Lead supporting Research & Development (R&D) Quality, Compliance & Audit, Learning and Performance (QCA L&P) function. -Developed project plans to address business need for a process document creation/revision. -Contributed to process modeling and conducting impact analyses, and assessment of process scope. -Coordinated with Business Process Owners (BPOs), Subject Matter Experts (SMEs), and stakeholders to identify and remediate areas of improvement in controlled documentation. -Authored process documentation such as standard operating procedures (SOPs), manuals, guidance documents, and other controlled documents within the document management system to address business needs and meet business goals. -Reviewed and provided quality assurance throughout the document lifecycle. -Proper archiving of compliance documents across the R&D department.



Cedars-Sinai

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory Coordinator III, Clinical Research Office- Samuel Oschin Comprehensive Cancer Institute

  • Oct 2018 - Jan 2019

  -Acting lead/supervisor of the Regulatory Core in the Clinical Research Office - SOCCI (Oncology Trials) -Training and education of new and existing regulatory staff members -Oversight and supervision of the SOCCI-CRO regulatory core -Provide primary regulatory support and oversight for advanced first in human (Phase I) Oncology trials -Facilitate and coordinate cancer clinical research within the SOCCI -Serve as a single point of contact for regulatory compliance -Assist in… Show more -Acting lead/supervisor of the Regulatory Core in the Clinical Research Office - SOCCI (Oncology Trials) -Training and education of new and existing regulatory staff members -Oversight and supervision of the SOCCI-CRO regulatory core -Provide primary regulatory support and oversight for advanced first in human (Phase I) Oncology trials -Facilitate and coordinate cancer clinical research within the SOCCI -Serve as a single point of contact for regulatory compliance -Assist in developing and maintaining an active protocol library accessible by all SOCCI cancer researchers and staff -Assist in developing and promulgating standards, policies, and procedures for the proper conduct of clinical research in accordance with ethical standards and in compliance with federal, state, and local regulatory requirements -Provide assistance and advice to investigators regarding FDA documentation including submission of IND applications; provide support for IRB submissions and communications -Facilitate clinical research by interfacing with research pharmacy, laboratory, pathology, medical records, budgeting, grants and contracts offices, and with external research sponsors -Experience conducting Medicare Coverage Analysis (MCA) for industry sponsored trials -Assist Regulatory Program Manager in conducting annual performance reviews for the SOCCI Regulatory Core.

• Regulatory Coordinator II, Clinical Research Office- Samuel Oschin Comprehensive Cancer Institute

  • Jun 2017 - Oct 2018

  -Facilitate and coordinate cancer clinical research within SOCCI -Serve as a single point of contact for regulatory compliance -Assist in developing and maintaining an active protocol library accessible by all SOCCI cancer researchers and staff -Assist in developing and promulgating standards, policies, and procedures for the proper conduct of clinical research in accordance with ethical standards and in compliance with federal, state, and local regulatory requirements -Provide… Show more -Facilitate and coordinate cancer clinical research within SOCCI -Serve as a single point of contact for regulatory compliance -Assist in developing and maintaining an active protocol library accessible by all SOCCI cancer researchers and staff -Assist in developing and promulgating standards, policies, and procedures for the proper conduct of clinical research in accordance with ethical standards and in compliance with federal, state, and local regulatory requirements -Provide assistance and advice to investigators regarding FDA documentation including submission of IND applications; provide support for IRB submissions and communications -Facilitate clinical research by interfacing with research pharmacy, laboratory, pathology, medical records, budgeting, grants and contracts offices, and with external research sponsors

• Regulatory Coordinator I, Clinical Research Office- Samuel Oschin Comprehensive Cancer Institute

  • Dec 2015 - Jun 2017



UC Santa Barbara

• Higher Education
• 700 & Above Employee

• Junior Research Specialist II, Laboratory/Center Manager

  • Aug 2012 - Aug 2015

  Responsible for the management and supervision of research conducted in Professor Jim Blascovich’s psychophysiology laboratory. Responsibilities include but are not limited to: -Coordinating general lab/center responsibilities including equipment maintenance and various levels of supervision/general management. -Hiring and training academic and undergraduate personnel. -Engaging in an independent leadership role managing various projects and research teams -Direct supervision of… Show more Responsible for the management and supervision of research conducted in Professor Jim Blascovich’s psychophysiology laboratory. Responsibilities include but are not limited to: -Coordinating general lab/center responsibilities including equipment maintenance and various levels of supervision/general management. -Hiring and training academic and undergraduate personnel. -Engaging in an independent leadership role managing various projects and research teams -Direct supervision of research involving human subjects and psychophysiological/medical equipment, including limited experience with fMRI. -Assisting with the development of stimulus materials for new studies, including piloting new programs and experiments. -Organization and scheduling of lab meetings, calendars, etc. -Collecting, processing, and analysis of self-report, physiological, observational and virtual reality data using various statistical techniques and programs such as SPSS, Microsoft Excel, MindWare, and other in-house software. -Troubleshooting and repair of VR hardware/software. -Resolution of conflicts and difficulties that may arise with subjects and/or between other members of the research team. -Preparation, revisions, and renewals of IRB (Human Subjects Board) protocols, including those involving the use of medical and VR equipment.

• Lab Manager & Junior Research Specialist II

  • Jun 2012 - Oct 2014

  -Collaborated directly with Professor Jonathan Schooler managing and assisting with anything and everything required in order to maintain an effective and efficient laboratory: -Lead project coordinator of all World Views & Behavior research projects within the lab. -Prepared grant progress reports. -Budget consolidation. -Preparation, revision, and renewal of IRB (Institutional Review Board for Human Subjects Research) protocols. -Interviewed, hired, and trained research… Show more -Collaborated directly with Professor Jonathan Schooler managing and assisting with anything and everything required in order to maintain an effective and efficient laboratory: -Lead project coordinator of all World Views & Behavior research projects within the lab. -Prepared grant progress reports. -Budget consolidation. -Preparation, revision, and renewal of IRB (Institutional Review Board for Human Subjects Research) protocols. -Interviewed, hired, and trained research assistants and subsequent lab mangers. -Inventory/purchase of supplies and equipment. -Research design and experimentation. -Statistical analysis and interpretation of research data using programs such as SPSS. -Coordinated lab communications both within the lab and between collaborating research labs. -Sustained a productive and organized lab for the principal investigator, post- doctoral/visiting researchers, and graduate students.

• Research Assistant

  • Apr 2011 - Dec 2012

  -Independently supervised and ran human research participants through multiple studies examining the relationship between video game use and cognition. -Coded and entered various forms of data using excel. -Assisted in literary research and review for meta-analyses. -Responsible for set-up and takedown between experiments. -Recruited participants based on precise inclusion/exclusion criteria. -Facilitated collaboration between other research labs on campus.

• Research Assistant

  • Jun 2011 - Aug 2012

  -Supervised and ran research participants through experiments involving interactions with virtual humans and environments. -Attended and contributed to weekly lab meetings. -Collected, entered, and analyzed self-report, physiological, and virtual reality data using AcqKnowledge, Excel, SPSS and MindWare. -Proposed, developed, ran, analyzed, and presented an independent experiment. -Literary research and review.



Costco Wholesale

• United States
• Retail
• 700 & Above Employee

• Cashier

  • Jul 2008 - Jul 2012

  Worked diligently and efficiently to complete transactions in a fast pace working environment. Provided executive member service by maintaining a professional, personable, and genuine demeanor. Responsible for gathering and organizing daily paperwork after business hours. Effectively communicated with various levels to ensure a positive work environment. Trained new cashiers on how to properly operate equipment and interact with warehouse members. Worked diligently and efficiently to complete transactions in a fast pace working environment. Provided executive member service by maintaining a professional, personable, and genuine demeanor. Responsible for gathering and organizing daily paperwork after business hours. Effectively communicated with various levels to ensure a positive work environment. Trained new cashiers on how to properly operate equipment and interact with warehouse members.



Straight Up - Reality Improv Connection Inc.

• Ventura County

• Youth Representative/Intern

  • Feb 2008 - Aug 2008

  -Represented youth at city hall meetings, events, and presentations aimed at addressing issues of underage and binge drinking among 15 to 25 year olds in Ventura County using improvisation and interactive performance/workshops with engaging discussion, exploration of issues, and the development of personal and community solutions. -Performed, organized, promoted and spoke at events known as “Reality Parties” in which parents are actively involved and educated about the dangers of binge… Show more -Represented youth at city hall meetings, events, and presentations aimed at addressing issues of underage and binge drinking among 15 to 25 year olds in Ventura County using improvisation and interactive performance/workshops with engaging discussion, exploration of issues, and the development of personal and community solutions. -Performed, organized, promoted and spoke at events known as “Reality Parties” in which parents are actively involved and educated about the dangers of binge drinking in teens and young adults. -Served as a youth author and contributed to writings on the dangers of underage drinking and alcohol abuse. Show less -Represented youth at city hall meetings, events, and presentations aimed at addressing issues of underage and binge drinking among 15 to 25 year olds in Ventura County using improvisation and interactive performance/workshops with engaging discussion, exploration of issues, and the development of personal and community solutions. -Performed, organized, promoted and spoke at events known as “Reality Parties” in which parents are actively involved and educated about the dangers of binge… Show more -Represented youth at city hall meetings, events, and presentations aimed at addressing issues of underage and binge drinking among 15 to 25 year olds in Ventura County using improvisation and interactive performance/workshops with engaging discussion, exploration of issues, and the development of personal and community solutions. -Performed, organized, promoted and spoke at events known as “Reality Parties” in which parents are actively involved and educated about the dangers of binge drinking in teens and young adults. -Served as a youth author and contributed to writings on the dangers of underage drinking and alcohol abuse. Show less