SUMMARY:

• Accomplished, articulate writer with proven ability to produce results in a fast - paced environment with critical deadlines.
• Demonstrated skill for managing multiple projects while focusing on details. Expertise in achieving results through effective communications with internal and external vendors.
• Understands basic design principles.
• Experience in pharmaceutical and medical device industries ( Confidential -regulated) editing end-user Technical Service and Operations Manuals, toxicology documents for Confidential submissions, and SOP’s for Regulatory Affairs and Quality.
• Developed and implemented a change management communication plan. Also developed communication channels.
• Experience interacting with and producing work for C-suite level.
• Experience managing others.
• Trained non-technical users how to use software to accomplish work goals.
• Can adapt known solutions to new situations and initiate change(s).
• Able to make a decision once possibilities are weighed.
• Learns quickly. Responds quickly to change. Thrives on challenges.
• Able to “think outside of the box”. High-level intellectual curiosity to gain a thorough understanding of unfamiliar concepts.
• Strong organizational, problem solving, and time management skills.

TECHNICAL SKILLS:

Computer Platforms: Fluent: Macintosh, PC

Agile-related Software: Functional: JIRA, AxoSoft, Trello

Computer-based Training: Fluent: ISOTrain

Database: Microsoft Access, MultiMate IV

Desktop Client/Electronic Mail: Fluent: Lotus Notes, Microsoft Outlook

Diagram/Wireframe Software: Limited Exposure: Microsoft Visio

Document Management Systems: Confidential Professional, Confidential Reader, Functional: SharePoint 2010, 2013; Enovia, SAP DMS Confidential, Blackboard

Enterprise Resource Management: PeopleSoft (Human Resources and Employee Performance HRMS )

Financial Management: Quicken, Quickbooks

Graphics Applications: Freehand, Microsoft Paint, Super Paint, Adobe Photoshop, Adobe Illustrator

Graphics Editors: Adobe ImageReady, Macromedia Fireworks

Graphics Inspection (Automated): ArtProof

Image Capture: Extensis Portfolio, Snag-It, Greenshot

Image Management: Fluent: Extensis Portfolio

Instant Messaging: Fluent: Lync 2013, Jabber, Sametime, Microsoft Communicator

IT Service Management (ITSM): Fluent: Remedy ITSM

Microsoft Office Suite Applications: OneNote

Operating Systems: Microsoft Windows 8.1/ 7/XP/95, Mac OS X.3.9, 9.2, 9.1, 8.6, Microsoft Vista, Microsoft Windows 2000/98, Unix

Page Layout Software: QuarkXPress, Adobe InDesign, Microsoft Publisher, PageMaker, Corel Draw, FrameMaker 12, 9

RELEVANT WORK EXPERIENCE:

Technical Writer

Confidential, Lake Forest, IL

Responsibilities:

• Confidential Redline implementation and verification.
• Compared Confidential 's to Confidential 's to ensure quality, clarity, and consistency across a range of client's Confidential regulated (medical) documents.
• Reviewed original copy during creation of initial versions of technical service manuals (TSM) and standard operation manuals (SOM).
• Assess copy looking for sequence of thought, logic, flow, and consistency. Flexibly adapted to changing priorities and client standards which were specific to the documents or labels as opposed to the standard usage of language. Able to execute high-quality work while meeting tight deadlines.
• Routed documents through an electronic system.
• Accurately proofread copy; including all graphics, charts, and text; for accuracy, grammar, spelling, consistency, referencing and annotation in preparation for medical/regulatory review as well as for conformity to established client style which was specific to the label as opposed to the standard usage of language. Did not rewrite copy. Routed documents through an electronic system.

Technical Writer

Confidential, Brookfield, WI

Responsibilities:

• Created SQA Documentation Plan as well as many templates for recurring documents. Self-taught Agile Scrum methodology as office transitioned from Waterfall methodology. Created a document creation and approval process. Created Project Proposal Template and individual proposals for team document projects in MS Word. Created template for the documentation of the team's software tests for a future off-shore testing team in MS Word. Managed the initiation of the revision of the software manual for the company's flagship product. This included a software review and adoption of Adobe Technical Communicator Suite 5 (in particular FrameMaker) for document production, training production, and XML code creation. Initiated the creation/adoption of two MS Outlook group mailboxes to streamline communications between site locations and external customers.
• Led team of developers to create SharePoint (SP) site to facilitate collaboration between SQA team members and other company employees. The SP site was a central repository for SQA testing and technical writing documents. Determined site information content. Designed site layout. Input data. Managed site access (permissions).
• Helped the SQA Manager with day-to-day team operations. Led team meetings in manager's absence. Tracked team members work effort to assure timely completion of projects and sprints. Tracked team members' work efforts on Trello boards (Kanban-style activities boards). Also tracked work activity in AxoSoft (JIRA-style project management software). Discussed with manager how to improve team efficiency, communication, and interactions. Initiated daily team meetings prior to Agile stand-up-meeting practice adoption. Recorded meeting minutes in MS Word.
• Created a MS Word template to refine the software requirements gathering process for the Implementation and R&D teams to improve the quality of information collected for the Development Team. Worked with team members to in corporate the new software requirements gathering process into the recently adopted Agile Scrum process. The teams tracked their work in JIRA. Led software review team to find JIRA add-ons that would seamlessly streamline the process from requirements gathering (both functional and non-functional) to code creation to testing.

Change Control Analyst

Confidential, Lake Forest, IL

Responsibilities:

• Worked on the R&D IT Change Management Team. Created department-specific and enterprise-wide communications in MS Word concerning the company's hardware/software separation and upgrades due to AbbVie's separation from Confidential
• Primarily created communications for the Lotus Notes Decommissioning and Application Migration Threads (project teams).
• Created and implemented multiple communication plans in MS Word, including a master communication plan, for the Separation project.
• Helped create guideline documents for communication creation for the project managers. Initiated Separation Program branding.
• This became the Separation program "Look and Feel" concept which was picked-up and expanded upon by the Enterprise. Initiated the creation/adoption of thread-specific MS Outlook group mailboxes to streamline communications and enhance Separation Program recognition.
• Created and optimized a Separation Program SharePoint (SP) site to facilitate collaboration between communication team members and the Thread Leads (Project Managers).
• The SP site served as a central repository for Separation communication documents.
• Made decisions as to the design/information content and layout of same SP site as well as input data and managed site access (permissions). Recorded meeting minutes in MS Word.

Documentation Writing Analyst (Technical Writer)

Confidential, Northbrook, IL

Responsibilities:

• Optimized existing SharePoint site for enhanced user-ability.
• Site was presented to the company CEO and other top-level executives to aid in the decision process about making SharePoint the default collaboration tool enterprise-wide.
• Made decisions as to the design/information content and layout of same SharePoint site as well as input data and managed site access (permissions).
• Co-edited the senior leadership team newsletter focusing on the top levels of the company, including the CEO.
• Newsletter production included design, layout, story selection, editing, and desktop publishing for both print and electronic delivery in MS Word.
• Worked with the corporate communications team on enterprise-wide notices concerning the company's enterprise-wide hardware/software upgrade.

Experis/Manpower Professional

Confidential, Confidential Park, IL

Responsibilities:

• Coordinated production of electronic newsletter for global CAPA program.
• Managed the CAPA program participant database, including input of participant program progress. Developed relationships with internal vendors to ensure accurate and timely international delivery of program instruction materials.
• Coordinated output of newsletter to CAPA program participants, including editing/proofreading.
• Organized CAPA instruction materials for use domestically which saved Confidential hundreds of dollars in reprint costs.
• Weekly mailed certifications to CAPA class participants. Created tracking system to ensure all participants received their certificates saving Confidential money by reducing duplicate printing and shipping costs.

Documentation Specialist

Confidential

Responsibilities:

• Worked on documentation team that prepared three Confidential for Confidential submission using Confidential .
• Provided quality control (QC) review of documents submitted to the Confidential to ensure accurate bookmarking/hyper-linking using Confidential Professional.
• Formatted reports for submission to Confidential .
• Interacted with Study Directors & Associate Pathologists/Toxicologists for clarity of the reports during submission process.
• Imported documents into Confidential electronic submission program ( Confidential ).
• Scanned and archived drug study submission documents.

Initial Public Offering Specialist

Confidential, Elk Grove Village, IL

Responsibilities:

• Reported directly to company vice-president.
• Assisted VP in strategic planning and implementation to secure funding for the IPO by applying my knowledge of business funding and development to research potential sources of funding and investors.
• Stockholder/potential investor database management/produced reports.
• Designed direct-mail solicitation for accredited (high-net worth) potential stock buyers in MS Word.
• Composed correspondence in MS Word. Set/confirmed appointments for potential investor pitch meetings.
• Packaged/mailed mass mailings to potential investors. Answered multi-line phone.

Professional Consultant

Confidential, Oklahoma City, OK

Responsibilities:

• Input data using limited HTML to convert paper-based tests to online version.
• Proofread copy to detect errors in spelling, punctuation, and syntax.
• Determined size and arrangement of illustrative material and copy, selected style and size of type and based layout on available space, knowledge of layout principles and aesthetic design concepts.
• Studied illustrations and photographs to plan presentation of materials, products, and services.