Technical Writers Resume Profile

CAREER SUMMARY:

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.

PROFILE:

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 training 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, OIG Guidance, as well as Food, Drug and Cosmetic Act.
Excellent skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.
Experience with Regulatory requirements, CMMI for configuration management, SOX guidelines, ISO standards, and Code of Federal Regulations 21 CFR Part 11, 210 and 211 .

PROFESSIONAL EXPERIENCE:

Manager Office of Compliance and Ethics

Trained in the review and final review and approval of promotional and sales training 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 OIG 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

Senior Technical Writer User Support Group

Wrote, edited, planned, and developed task-oriented CMMI compliant user guides, and release notes for web applications used by the NIEHS and contract laboratories to collect clinical trial data for the National Toxicology Program studies.
Wrote, edited, and developed training 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.

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