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Microsoft Office Manager

Location:
Trenton, New Jersey, United States
Posted:
November 06, 2018

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Resume:

James L. Johnson Jr. 609-***-****

Hamilton, NJ **619

ac7mhk@r.postjobfree.com

LinkedIn

SUMMARY

Result oriented in Pharmaceutical Submissions with a proven track record of adapting to new assignments in a quick and timely fashion. Highly competitive individual whose motivational skills is top notch. Versatile skillset stemming from 24 years of handling multiple projects efficiently and accurately. Excellent time-management and organizational skills. Currently in pursuit of a company that encourages multitasking thereby enhancing my credentials and the organization’s growth.

PROFESSIONAL EXPERIENCE

Cognizant Technologies Solutions, Bridgewater, NJ 2017-2018

Programmer Analyst – Regulatory Affairs, 2017-2018

Responsible for the preparation, tracking, compilation, publishing and technical quality control of all regulatory submissions.

Verify, edit, dispatch and publish documents for the submission to worldwide Health Authorities (FDA & CA).

Working in close collaboration with the Global Submission manager for publishing process.

Ensure adherence to internal standards and processes, as well as Health Authority’s requirements.

Reporting and updating for Submission Publishing on submission progress.

Identifying issues and solutions relating to timing, quality and resources.

Bristol-Myers Squibb Co., Hopewell, NJ 1993-2017

Submissions Operations Coordinator, 2014-2017

Manage electronic regulatory files, associated emails, training files and other supporting regulatory documents, communication, with and assisting organization staff with audit proceedings. Provided support during regulatory agency inspections and external audits.

●Managed all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance regulatory submissions.

●Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA & EMA).

●Provided guidance and feedback to regulatory affairs management.

●Developed regulatory strategies for enhanced team performances.

Regulatory Safety Data Examiner, 1993-2014

Achieved submissions of reports and business partner expedited cases. Support GPVE audits and inspections ensuring all assigned observations and corrective action plans are completed in the required time frame.

●Energized team in meeting shared goals of accomplishing regulatory projects effectively.

●Assisted in the development and maintenance of regulatory files, records and reporting systems.

●Performed QA of all regulatory documents before submission to the NDA and FDA.

. .

EDUCATION / TRAINING

Bachelor’s Degree, Business Management

Kean College, Union, New Jersey

Associate’s Degree, Business Administration

Middlesex County College, Edison, New Jersey

TECHNICAL SKILLS

Microsoft Office – Word 2013, Excel 2013, Microsoft Outlook 2013 and Skype for Business 2017, Serial Number Database, BIRDS for Advanced Authors, Documentum (Archiver, First Doc, Lorenz Validator), ISI Toolbox, Liquent InSight Publisher, Liquent InSight Excel Magic, AWARE, CARES

CERTIFICATIONS

Received online training certificate courses in AWARE HQ Submissions, Data Privacy for AWARE and AWARE System Overview.



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