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Project Office Assistant

Location:
New London, Connecticut, United States
Posted:
October 18, 2018

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Resume:

Lyuba Boyko

*** ******** *** *** ******, CT ***** 860-***-**** ac7feb@r.postjobfree.com

MAJOR COMPETENCES

As a dedicated and knowledgeable professional with experience in pharmaceutical regulatory operations coordinating and executing publishing solutions & managing product delivery to regulatory agencies, I seek to bring my skills and abilities to add value to your company.

- Effective utilization of logical and creative thinking to work towards resolutions

- Time management skills and priority setting to efficiently carry out responsibilities

- Enthusiastic learner, eager to meet challenges and quickly assimilate new concepts.

- Outstanding ability to multi-task whilst maintaining high-level organization in a changing environment with numerous competing deadlines.

- Adept ability to work well individually and within a multi-dimensional team environment.

- Extensive experience in professional, office settings, using a variety of administrative and data processing tools: Microsoft Outlook, Word, Excel, Project Management; Adobe - PDF Professional, ISITool.

KEY SKILLS

- Develop and maintain design dossier/ product technical files, ensure compliance and the timely and accurate filing of regulatory documentation.

- Coordination & execution of project specific paper and electronic submissions

- Publishing solutions management to meet unique requirements of each submission

- Submissions delivery management to regulatory agencies via established electronic gate

- Expert knowledge in Microsoft Outlook, Word, Excel, Project Management; Adobe - PDF Professional, ISITool

- Working knowledge of electronic and paper publishing systems and tools

- Working knowledge of QC/QA practices to preserve regulatory and internal compliance

- Acquisition of source documents for referenced literature to preserve Copy rights regulations

- TMF filing via a coding specifications system

- Regulatory Initial Drug Shipment Release processing

- Proofreading

- Records Retention/Storage

PROFESSIONAL EXPERIENCE

SG RESEARCH INTERNATIONAL for Iterum Therapeutics

Contractor/Consultant, November 2015 – May 2018

Regulatory Operations Submissions Management

TMF filing

Medical coding

ICON/DOCS for Durata Therapeutics Inc.

Contractor/Submissions Specialist, May 2013 – July 2015

E-submissions preparation - New Drug Applications, Marketing Authorization Application, Application to PDP, Pharmacovigilance Risk Assessment Committee, Labeling & Application to Office of Prescription Drug Promotion– processing eCTD components (formatting, creation of internal and external hyper-text links)

Literature References – acquisition of source documents via web-based search engines applying Publishers copy rights regulations

TMF – utilization of a coding system & data repository filling system

Initial Drug Shipment Release Regulatory process – receiving, review & approval of documentation packages via web-based tracking system

Research for and Compilation of various reports for Regulatory and Clinical teams

PFIZER Inc.,

Worldwide Safety & Regulatory Operations, Medical Division Submissions Specialist, October 2004 - September 2012

Delivered project specific Pfizer paper and electronic submissions

Coordinated and executed publishing solutions to meet unique requirements of each submission

Managed product delivery to regulatory agencies

Maintained working knowledge of electronic and paper publishing systems

Achieved a fluent level of skill for multiple dossier format and publishing requirements

Maintained ongoing liaison with Project Team representatives to ensure paper and electronic submission requirements and time lines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional markets

Actively participated in the definition, investigation and implementation of regional and global process efficiencies for paper and electronic submission publishing, including the evaluation of current processes

Maintained leadership/participation on global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions

Maintained interpretation of regulatory guidelines to produce business requirements and ensure those requirements are implemented

Maintained monitoring of a safety reporting portal, adhering to appropriate working practices, following with a filling to FDA

Maintained forecasting and management of project specific resources, global load sharing as normal business practice

Maintained appropriate use of technical tools, working practices and QC/QA regimes, regulatory and internal compliance preservation

Participated in the definition and implementation of regional process efficiencies for submission publishing and project learning sessions;

Achieved a Subject Matter level of expertise in dossier types and/or processes with responsibility for training and mentoring fellow colleagues

EDUCATION

Bachelor’s Degree in Electronic Technologies

Electro Machine Technical College, St. Petersburg, Russia, September 1983 – June 1987

Diploma, First year of a four-year Studies in Business Management Law St. Petersburg University of Management Technologies and Economy, St. Petersburg, Russia, June 1994 – June 1995

*** References Available Upon Request ***



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