SUMMARY

• Possess extensive data entry and administrative experience (13,000 ksph alphanumeric) in the bio pharmaceutical industry.
• Improved a document naming convention, reducing tracking time by 75 percent.
• Processed multiple similar product cases simultaneously, increasing productivity by 300 percent.

PROFESSIONAL EXPERIENCE

Confidential, North Brunswick, New Jersey

Data Entry Specialist

Responsibilities:

• Serve as the first - line-of contact to support numerous accounts.
• Use an ERP system to export data and update Excel logs with volumes (hundreds to thousands) of product-related data and manage procedural documentation.
• Update daily departmental project status reports of volumes of projects, using file servers and Excel files daily and submit to company owners and all levels of management via e-mail.
• Serve as an Electronic Data Management Systems (EDMS) super-user. Participate in product/process development projects, ensuring documentation process adherence.
• File physical and electronic report forms, output and other related source documents.
• Work in a team environment and with at least three levels of management.
• Comply with Standard Operating Procedures.

Confidential, Somerset, New Jersey

Document Control Clerk

Responsibilities:

• Coordinated medical device document management activities to support local as well as global customers.
• Managed volumes (50/product) of entries of product-related data, using various MS Excel spreadsheets and Access databases.
• Served as an EDMS super-user. Participated in product/process development projects, ensuring documentation process adherence.
• Interfaced with Regulatory and all departments.

Confidential, Cranbury, New Jersey

Data Entry/Analyst /Documentation Assistant

Responsibilities:

• Used databases and spreadsheets to perform volumes of data entry (200+ invoice and transactions daily) from source documents.
• Assisted with the processing and filing of reports. Worked as a team member.
• Complied with company and departmental Standard Operating Procedures.

Confidential, Edison, New Jersey

Support Services Contractor

Responsibilities:

• Performed RAVE administration tasks per Company process to support global clinical trial studies conducted by pharmaceutical firms and CROs.
• Using MS Excel source files, efficiently entered volumes (150 + daily) of client data and specific client requirements in RAVE to support user and site administration.
• Took on additional responsibility of quality checking and verifying hundreds of patient data on CDs to be sent to CROs and pharmaceutical companies and ultimately the FDA for approval.
• Logged all incoming tasks in Horizon (Siebel based), a call tracking system.
• Complied with Standard Operating procedures.
• Communicated with clients and worked in a team environment verbally and via e-mail.

Confidential, Plainsboro, NJ

Data Entry contractor

Responsibilities:

• Efficiently entered, updated, and verified volumes of new descriptive pharmaceutical and clinical file names (100/daily) in a custom MS Access database, containing a built-in MS Excel worksheet, MS Excel PDF and MS Word files.
• Consulted peers on document regulatory compliance.
• In the absence of peers and my manager, supported management.
• Filed physical and electronic source documents.

Confidential, Bridgewater, New Jersey

PQC Technician

Responsibilities:

• Assisted with the processing of volumes of safety reports and cases (non adverse), query generation and resolution, using Siebel and a global SAP database. Processed similar cases simultaneously, reducing processing time by 300 percent.
• Ensured proper coding of events and drugs for cases in PQC SAP database.
• Assisted with safety database entry and publishing follow-up letters to clients.
• Provided feedback to product analysts to obtain corrections to incoming complaint information, including problem code corrections and requests for additional information.
• Ensured correct problem codes and failure code classifications are assigned to ensure accurate trending for complaint data analysis.
• Audited and followed up with product analysts regarding drug data inconsistencies for resolution.
• Communicated with clients and worked in a team environment.
• Complied with Standard Operating Procedures.
• Responded to volumes of calls and e-mails from clients, using MS Outlook.
• Searched, entered, audited and managed data in CARS, MS Excel and Word files.
• Reviewed and processed volumes of applications, using MS Word, Excel and web sites.

Confidential, Whitehouse Station, New Jersey

Contracts Administrator contractor

Responsibilities:

• Reviewed requisitions, received from all Divisions of Merck, using Ariba and SAP, for products and services within established timeframes to ensure enablement of the end-to-end process, as well as meet the needs of the business.
• Interfaced with all levels of management within Merck.

Confidential, Hopewell, New Jersey

CMC Document Specialist

Responsibilities:

• Supported drug-related activities via entry and quality control, using IRIS and Documentum, in a fast-paced environment.
• Trained users on and entered data in IRIS for heavy entry, data management (drug product and substance and related data), report processing, query generation and resolution.
• Improved a document naming convention, reducing tracking time by 75 percent.
• Successfully completed online and in-person LIMS training courses to enter, store and track laboratory data and related information. Assisted users with the same.
• Managed and distributed volumes of records and reports to management and peers for data integrity.

Confidential, Kenilworth, New Jersey

Administrative / Application Consultant

Responsibilities:

• Supported a manager, four clinical research associates in processing medical data for various clinical trial studies and protocols and with MS Office applications.