Management Project

Eric Etter

**** **** *****

Los Angeles, CA *****

323-***-**** *****-*******@*******.***

SUMMARY OF QUALIFICATIONS

Extensive experience within the Data, Document Control & Records Management environments with a strong emphasis in the Bio/Pharmaceutical industry.

Experience and understanding of document control/database programs such as Documentum and similar programs

Provision of strategic advice to client upper management teams on project feasibility, project delivery and procurement methods

Proven ability to organize and manage document control teams to effectively deliver analysis, appraisal and forecasts on document control reporting functions

Experience preparing and analyzing project schedules at all levels

Ability to accurately track project schedule progress against time and budget expenditure, including development and implementation of mitigation and corrective action strategies when required

Demonstrated client management, communication and organization skills

Coordination with large, multi-layered project teams including project management, design consultants and engineers, and contractors

TECHNICAL SUMMARY

20+ years of industry work experience in areas of operations and/or project technical support, including working experience with document management, and IT systems and tools.

Strong work ethic, attention to detail, and due diligence to effectively complete every task.

Ability to work independently, and exceptional critical thinking and analytic skills.

Extensive documentation, inventory control, archiving and retention/destruction of various records, including architectural and engineering drawings and plans.

Experience with Microsoft Windows applications such as Excel, Word, PowerPoint, Outlook, Adobe Acrobat, scanning and printing equipment, and an

ability to learn and master new application software.

Proficient use of Documentum, Metaphase, and various other Electronic Documentation Management Systems.

Experience using bar coding and optical imaging systems and scanning equipment.

Ability to actively participate as a member of a multi-disciplinary project team.

Knowledge of compliance/regulations within the aerospace, manufacturing, and product development environments.

Alpha, numeric and terminal digit filing and centralization of files and records.

Familiarity with both manually indexed and computerized records systems.

Experience training and supervising permanent and temporary records management staff in documentation and records management procedures.

EMPLOYMENT HISTORY

PUMA BIOTECHNOLOGY Jun 2015 – Jan 2019

Clinical Data Manager, Clinical Data Management

Performs general administrative duties in support of studies

Assists in identifying external data issues and tracks resolutions

Reviews listings to identify data discrepancies and tracks resolutions

Performs database design and edit check specification testing

Assists in other data cleaning and database lock activities as assigned

Participates in study team meetings as DM representative

Participates in vendor oversight management

Provides administrative assistance in document receipt, preparation, scanning/loading, naming and filing and tracking of key information for the conduct of clinical research studies.

Serves as the central repository function for receipt of clinical documents from various sources.

Works closely with study teams to assist with timely uploading of clinical documentation to the Client's Trial Master Files (TMFs) and to ensure accuracy, consistency and quality. Responsible for high level quality control reviews of TMF documents.

Assists with TMF document maintenance and tracking activities.

Aligns execution activities with agreed upon project priorities, timing and quality specifications.

PUMA BIOTECHNOLOGY Oct 2014 - Jun 2015

Document Specialist, Clinical Data Management (Contract)

Assisting the data management team in the day to day filing and maintenance activities of clinical studies during start up, maintenance and close out activities.

Research, uploading, maintenance and reconciliation of study documents in TMF

Cataloging of legacy documents and identification of gaps in clinical study related documentation

Completion of other study document related tasks as required by other departments such as Quality Assurance

Performance of general administrative duties to support clinical study activity.

EXXON MOBIL DEVELOPMENT COMPANY June 2013 - Sept 2014

Documents For Operations Coordinator (Contract Consultant)

Coordination of the communication efforts between the Project Team and Operations group to plan and execute Documents for Operations schedule and processes to meet Company Specifications and Timelines.

Ensure Company requirements for DFO are understood by the Project Team and its Contractors and Suppliers.

Interfacing daily with Project Team members to support identification of start-up, integrity critical and Ready For Operations deliverables.

Planning and conducting of DFO workshops, refresher training sessions and constant reiteration of DFO expectations and requirements to Project Team and its Contractors as necessary.

Guidance and Facilitation of resolution of DFO queries and deviations.

Monitoring of the Project Team progress of the review of DFO deliverables, turnover from the contractor to the Project Team, and handover to operations, weekly and monthly reporting of the status of DFO documentation review to handover cycle for tracking purposes.

Identification of Gaps and providing resolutions. Reporting of deficiencies to Information Management Lead

Transmittal of Early Deliverable / Final Deliverable information packages to Operations.

Proactively bringing attention to the Project Information Management Lead any issues that could potentially impact final documentation quality, cost or schedule.

Determination of the frequency of, and participation in DFO internal audits within the Project Team and external audits of Contractor and Sub-Contractor teams, to ensure resolution of issues raised.

Maintaining adequate performance measurements to support DFO progress and reporting.

Ensure all final DFO drawings, documents, and their associated attributes are progressively loaded into Company Electronic Document Management System (UDocs).

VALIDANT / QUINTILES CONSULTING May 2012 - Sept 2012

Document Management System Consultant

Defining of metadata, workflow mappings and document retrieval strategies for documentation and/or file management systems

Working with multiple user groups in identifying business process opportunities regarding document

management

Experience working with users to refine document management policies

Leading and performing document taxonomies studies.

Development of documentation to support the usage and modification of existing document management systems

Remediation of change control system documentation

Project management.

AMGEN, Thousand Oaks, CA Sept 2011-March 2012

Regulatory Project Coordinator (Contract)

Support the compilation, submission and archiving of regulatory dossiers

Maintain regulatory document management systems and tracking systems

Maintain core dossier components

Quality control of regulatory dossiers, archive and tracking systems

Primary Regulatory Operations point of contact between TAs/CMC and publishing teams

Maintenance of regulatory tracking systems: Data entry, administration of, and reporting from regulatory registration tracking system (IMR); maintenance of product history logs.

System administration: administration of document management systems; EPIC dictionary maintenance; maintenance of team SharePoint sites and associated documentation.

Electronic document management of ongoing submissions: collation of dossier components into document management system; virtual document build; literature reference sourcing; maintenance of EPIC core components for Emerging Markets.

Regulatory archive: submission of regulatory dossiers, agency correspondence and records of contact to regulatory archive; upload to document management system; maintenance of product history documents; IMR data entry and document linking; maintenance of virtual documents for currently registered details.

Quality control: submission ready components and submission dossiers; IMR data entries and links; regulatory archive locations and file naming.

Information requests: fill internal requests for information and documentation.

PAREXEL, Glendale, CA July 2010 - Sept 2011

Controlled Document Specialist,

Process Optimization & Management (POM)

Corporate Quality Services (CQS)

Coordination of Controlled document lifecycle procedures and maintenance of the Controlled Documents Library.

Liaison with internal and external clients regarding Controlled Documents

Tracking of scheduled review processes through spreadsheets.

Database maintenance

Posting and deleting documents within the controlled Documents Library in EDMS

Administrative work (filing, copying, formatting, editing, proofreading)

Transferring Word and Visio process maps into iGrafx Flowcharter

XENCOR, INC., Monrovia, CA July 2005 - Nov 2008

Documentation Specialist II/ QA Technical Operations

Overall responsibility for preparing and comparing quality and regulatory documentation within clinical, preclinical and technical operations for the development of biologic products proposed for oncology and autoimmune / inflammatory disease indications.

Maintenance of the document management system for controlled and un-controlled documents originating within the company and/or from contract laboratories.

Maintenance of the technical report system for capturing the development phases of various Xencor products, and the basic Xencor corporate memory.

Interaction with Regulatory and Clinical departments to assist in the assembly and submission of Regulatory and Clinical information to the FDA and worldwide regulatory agencies, including but not limited to, IND’s, manufacturing, pre-clinical, and clinical protocols and amendments, and adverse experience reports.

SPECTRUM LABORATORY PRODUCTS, INC., Gardena, CA June 2004 - Feb 2005

Records Management Specialist / Regulatory Affairs

Project, time and workflow management of regulatory affairs department records & documentation.

Extensive management of large, complex inventories.

Responsibility for upgrading and management of existing record system.

Ensured adherence to retention schedules.

Coordination of information creation, receipt, storage, retrieval and disposition of records.

Trained regulatory staff on processes, procedures and systems, and other duties as assigned.

BAXTER HEALTHCARE CORPORATION, Westlake Village, CA Sept 1997 - Oct 2003

Senior Documentation Specialist / Regulatory Affairs

Created, edited and processed documentation according to SOP’s, GxP’s and configuration manual guidelines with minimal supervision, and researched records as needed.

Identified more efficient documentation processes and updated procedures accordingly.

Provided assistance in preparing, processing, and delivering regulatory documentation to all plants.

Created structure and relationships using Product Data Management System (PDM).

Provided administrative support for Quality documentation systems under GxP with general supervision.

Administered document routing and review process and tracked document deliveries to completion.

Interfaced with development groups, technical support groups and personnel within the manufacturing facilities in solving product documentation problems.

Coordinated and advised engineers and plant personnel concerning documentation related issues.

Ensured appropriate documentation was complete, correct and that production schedules were met.

Coordinated activities with engineers, plants and support functions to meet production schedules.

EDUCATION

B.S. Business, University of Redlands,

Degree Program Completion Pending

Contact this candidate