Lori Lam

Regulatory Affairs/ Medical Writer & Communicator

CAREER SUMMARY

Successfully trained and supervised office personnel to meet goals and

objectives; educated community groups; prepared written reports for

regulatory submissions; collected, evaluated, and analyzed, performed

failure investigation analysis reports on returned products.

Skills Summary: Software: Word, Excel, FrontPage, PowerPoint, SPSS, Adobe,

HTML, Publisher, Statistical analysis with pivot tables/charts and graphs.

Key Qualifications: Clear and concise communication skills to persuade and

solve problems. Organizational and project management skills to set

schedules that maximizes efficiency and attention to details. Works well as

a team member or independently. Global communication experience. Supporter

of special projects that promote the goals of the organization. Medical

terminology. Assessment techniques. Fluent in English and Vietnamese.

PROFESSIONAL EXPERIENCE

Insound Medical (ISM), Newark, Ca 06/2011

- 12/2012

Product Analyst/ Medical Information Associate

. Chosen as leader to maintain and track a Beta Program with 12 provider

sites initially, which then escalated to 70 provider sites with the

following duties: return devices analysis, communication with

providers and sales rep., incentive planning, tracking, trending and

communicating results to marketing directors, R&D, management and

engineers with the use of pivot charts/tables and PowerPoint.

. Single-handedly manages complaint handling from opening to closure:

including follow up with providers/medical advisors to gather

additional health information, device investigation, and communication

from Switzerland & Vietnam to obtain information, accessing risk

management/analysis and trending data for FDA reporting/submissions

and compliance; compile information in various written documents.

. Reviews documents including clinical study reports, SOPs, analytical

procedures, engineering drawings and protocols and making corrections

as needed, then releasing as official company documents.

. Prepares, writes and submits reports to appropriate regulatory

agencies as required

. Maintains paper/electronic documents on legislation, regulations and

guidelines.

. Assists with internal audits and provides regulatory and guidance to

Quality Management.

Boston Scientific (BSC), Fremont, Ca

06/2010 - 06/2011

Product Analyst/ Medical Information Associate, Post Market Compliance

. Reviewed and managed domestic and international product surveillance

activities related to quality improvement, reliability, safety, and

effectiveness of all medical devices manufactured, marketed,

distributed and serviced by BSC.

. Collaborated with medical advisors, sales team, and other

professionals to collect applicable information related to the

complaint event for classification.

. Worked directly with Quality Engineers (QE) by reviewing failure

investigation report summaries on returned products.

. Reviewed customer complaints to determine reportability by following

corporate SOPs; proper documentation into the complaint management

system (GCS2); ensure timely closure of complaints and submission to

FDA.

. Responsible for writing and editing all US-based customer response

letters

. Knowledge of applicable domestic and international regulations and

standards, 21 CFR 820.198, 21 CFR Part 203, QSR, ISO 13485, 21 CFR

803, MedDRA, MedWatch

Life Scan - Johnson & Johnson, Milpitas, Ca

04/ 2008 - 01/2009

Regulatory Affairs Associate

. Compile, write and organize materials for pre-submissions (including

clinical studies, annual reports and responses to agency questions

regarding registrations and licenses) to the FDA and other global

regulators as needed.

. Comply with regulatory requirements for vigilance reporting through

the accurate and timely evaluation and processing of potential

reportable complaints for filing with the FDA and global regulatory

agencies.

. Reviewed, evaluated, and classified potential reportable complaints

for both U.S. and international affiliates; surpassing on average of

40 complaints/week with no late submissions.

. Recommendation accepted to change complaint handling procedure to

reduce the backlog situation

. Identified and properly assessed adverse events by collecting

clinically significant information via phone/email, facilitate

accurate data entry, prepare clear and concise narrative of event to

regulatory agencies and other medical staff daily

Santa Clara Valley Medical Center, San Jose, CA

03/2007 - 02/2008

Health Educator Associate

. Managed the Smoking Cessation Program, acting as a consultant to the

department of Respiratory Care.

. Counseled patients, discussed patient cases with other health

professionals and collected pertinent patient health information to

formulate proper treatment plans for patients to successfully quit

cigarette smoking.

. A program leader who successfully trained another associate in daily

activities to meet goals and objectives. Quarterly report showed a

record high of an additional 15% of patients who successfully quit

smoking while enrolled in the program.

. Analyzed, interpreted and trended data collected for clinical research

and for presentations to department.

. Wrote, edited, and prepared for print procedure manuals, reports,

brochures as well as host community outreach booths to raise public

health awareness.

. Familiar with State, Federal and SCVH&HS Policies and Procedures

related to the release of confidential patient information and

Medicare, MediCal.

. Followed hospital protocols, operations and procedures- HIPPA, IRB,

and JOINT Commission requirements.

EDUCATION

BS, Health Science, concentration - Health Service Administration

. San Jose State University, San Jose, 2007

. Honors and Awards: Dean's List

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