Gary Daniel Email & Phone Number

Responsible in marketable mail processing thru DATS data base by facilitating and handling marketable submission.•Accountable for initial data entry processing to identify marketable record such as generate log number, barcodes documents, scan and submission reports.•Responsible for Quality Assurance to review, flag and sort Applications and Non-applications distribution.•Perform initial routing task to designate recipient in distributing submission consist of a copy or multiple volumes for reviewer.•Participates in procedural filing Marketable submissions, shelf inventory and provides weekly reports. Identifying and tracking mail processing batch related to the application related submission such as BLA, Medical Device Files (510K), Special (510K), New drug Application (NDA), Pre-INDs and PAS Application.•Provide direct support to the Project Manager and supervise at staff of 12 Records Managers.•Developing and documenting procedures/database, scheduling tasks, completing statistical reports.•Perform Quality Control on regulatory submissions and technical support work.•Analyze all incoming and outgoing documents to distinguish appropriate data entry, routing, and quality control.

Responsible in marketable mail processing thru DATS data base by facilitating and handling marketable submission.•Accountable for initial data entry processing to identify marketable record such as generate log number, barcodes documents, scan and submission reports.•Responsible for Quality Assurance to review, flag and sort Applications and Non-applications distribution.•Perform initial routing task to designate recipient in distributing submission consist of a copy or multiple volumes for reviewer.•Participates in procedural filing Marketable submissions, shelf inventory and provides weekly reports.•Identifying and tracking mail processing batch related to the application related submission such as BLA, Medical Device Files (510K), Special (510K), New drug Application (NDA), Pre-INDs and PAS Application.•Implementation of new database.•Plans and organize, schedule, evaluate and assign work.•Analyze and research complex records cases to resolve problems.•Track and process Regulatory applications.•Handles routine complaints.•Works closely with team members to reduce error rates.•Served as main point of contact for property control. Ensured that inventory was accomplished according to schedule, and that sensitive items were signed for, and that property identification tags were affixed to the property.

Twelve years of experience with FDA/CBER Mail and Courier Services to provide standard operation procedures that is necessary to fulfill all contractual obligations with accuracy, safety, reliability, timeliness, courteousness, responsibility, speed, security, and appearance•Responsible for the complete scheduled and unscheduled courier runs which include scheduled morning/midday/afternoon extramural runs•Scheduling morning NIH Mailroom pick-up/drop-off runs. •Unscheduled runs to NIH, MPN, PKLN, PARK, RKWL I and II, Wilkins, NLRC, CORP, OAK, etc.•Completions of runs require the use of government vans. Couriers must comply with the usage guidelines, requirements, and restrictions which apply to the use of government vehicles•Sort incoming mail into Regulatory and Non-Regulatory classifications.•Sort incoming mail into First Class, Interoffice, Bulk (including 2nd, 3'd, 4'h class, and Non-profit) Mail•Further sort mail according to name/or mail code and/or location (e.g. PKLN bag, NIH crate; outgoing to be metered)•Receipt and Process of Express, USPS Certified, and other types of Regulatory and/or Signature controlled mail•Use of log sheets for initial receipt and delivery•Data entry of air-bills and DLS for control of non-regulatory/regulatory documents and parcels•Acknowledge receipt of documents and packages (use date stamp, signature, initial)•Metering Outgoing Mail•Sort and meter outgoing mail to be sent to domestic and international addresses via the USPS.•Fix the correct postage for USPS certified, registered and return receipt services.•Photocopying•Processing of send back materials •Support IND and Marketable staff•Assist 'walk-up DCC/CBER clients at the door, filing and answering telephone; Enter IND’s and correspondence into various data base•Responsible for general filing and reshelving records.•Perform retrieval and routing of requested records.•When instructed shreds copies.•Responsible for picking-up applications from various divisions.•Assist in upgrading internal procedures.•Additional support activities as requested by supervisor

General Education

General Education