Compliance manger, policy analyst, technical communicator, project manager, validation specialist, trainer, usability tester, and medical technologist. Specialized knowledge extends from research and clinical laboratories to a healthcare consulting firm, pharmaceutical and semiconductor manufacturing facilities, and a microcontroller design center.
- Solid understanding of promotional and labeling materials that must comply with relevant laws and regulations as well as review and approval of promotional and sales materials lifecycle, and corporate communications and monitors changes in US labeling and promotional, regulations as well as corporate policies and procedures.
- Excellent understanding of drug development process, GAMP4, GxP, SDLC, software systems, and advanced system - on-a-chip technology.
- Knowledge of federal fraud and abuse laws, including anti kickback laws, False Claims Act, FCPA and related statutes, existing and emerging state law, PhRMA Code, Confidential Guidance, as well as Food, Drug and Cosmetic Act.
- Excellent skills at facilitating teams and building consensus with comprised of diverse levels and areas of the company.
- Experience with Regulatory requirements, Confidential for configuration management, SOX guidelines, ISO standards, and Code of Federal Regulations.
Confidential, Lawrenceville, NJ
Manager - Office of Compliance and Ethics
- Trained in the review and final review and approval of promotional and sales materials, and corporate communications.
- Ensures product promotional materials are submitted to Office of Prescription Drug Promotion (OPDP) on the appropriate forms in a timely manner as per regulations, and that materials are archived as per company policy.
- Assisted with setting up procedural document governance department as part of a newly formed Office of Compliance and Ethics Department in accordance with Confidential guidelines.
- Write, edit, and develop effective corporate procedural documents using accurate and timely information regarding US and international laws and regulations, as well as industry practices and trends.
- Conduct compliance audits and monitor speaker programs for compliance with corporate procedural documents and US healthcare laws.
- Manage interdisciplinary development teams to ensure development of procedural documents represents the Company’s compliance with US and international laws and regulations.
- Coordinate and manage team activities to assure project objectives are met and delivered on time.
- Provide gap analysis of process descriptions to writing teams during document development to ensure processes are accurately captured.
Confidential, Durham, NC
Senior Technical Writer
- Wrote, edited, planned, and developed task-oriented Confidential compliant user guides, and release notes for web applications used by the Confidential and contract laboratories to collect clinical trial data for the Confidential studies.
- Wrote, edited, and developed materials and courses for laboratory personnel who use relational database web applications for data entry of clinical studies.
- Provided recommendations and gap analysis of processes to improve current documentation.
Confidential, Morrisville, NC
Senior Technical Writer/Validation Specialist
- Wrote and edited SOPs, guidelines, and SDLC documents for cGMP Quality systems related to development, production and testing according to Code of Federal Regulations and cGMP as promulgated by the FDA.
- Wrote, edited, and developed VPs, SRS, SDS and test cases for validation of EMAC system, EM and SQL*LIMS according to GAMP 4 and SOX guidelines.
- Documented application development, procedures, and flowcharts for remediation of specific process systems.
- Created process mapping, gap analysis, lessons learned, and benchmarking of validation and GMP regulations to enhance and improve current remediation methodology.
Confidential, Durham, NC
- Wrote, edited, planned, designed, and developed task-oriented 8/16-bit Confidential microcontroller user manuals and applications, data sheets, specifications, tutorials, engineer application notes, as well as SDK documentation.
- Supervised, trained, and assisted contract technical writers with developing their deliverables to meet preset deadlines, and advised them in matters of style, syntax, and usage to improve the general quality and effectiveness of technical documentation.
- Managed and controlled confidential and proprietary technical documentation in compliance with ISO 9000 standards.
Confidential, Durham, NC
- Performed quantitative and qualitative analysis of Chemistry, Hematology, Urinalysis, and Toxicology patient samples in a STAT lab using GLP.
- Wrote clinical laboratory SOPs for analytical instrumentation and clinical procedures.
Confidential, San Francisco, CA
- Performed quantitative and qualitative analysis in virology and serology using GLP.
- Performed tissue culturing using GLP.
- Wrote, edited, and reviewed HIV and STD reports and laboratory SOPs.