Technical Writer Medical Device
Resume:
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•Independently author, edit, and format clinical and regulatory documents, Clinical Evaluation Reports (CERs), and Clinical Evaluation Plans (CEPs) to meet EU Medical Device Regulations.
•Conduct medical literature searches in the Cochrane Library and PubMed for use in CERs and CEPs.
•Interpret non-clinical data, such as field population data, customer complaint data, engineering change orders, and field safety data, for use in the CERs and CEPs.
•Manage the collaboration of cross-functional teams, such as System Engineering, Compliance, Regulatory, Quality Assurance, Clinical, and Project Engineering, to prepare documentation for stakeholder review, approval, publication, and submission to regulatory agencies.
•Conduct final reviews of proposed publications for style, design, layout, and editorial aspects before management approval.
•Develop proficiency in quality system procedures and medical device standards for compliance with Class I, Class IIb, and Class III medical device regulations.
•Track project documentation through creation, approval, publication, and life-cycle updates.
•Ensure timeline adherence and provide project status updates on a regular basis for each assigned project.
•Contribute to the development and maintenance of the Clinical Affairs working practices and procedures, as well as help update and maintain CER, CEP, and Regulatory templates.
ALICE MICHELLE SHILLINGS
: 364 Childe Harolds Circle – Brentwood, TN 37027
: 206-***-**** : *****************@*****.*** www.linkedin.com/pub/michelle- shillings/0/b15/7ab/
PROFILE SUMMARY
•Versatile and professional Technical Writer with years 20+ years of experience crafting technical details into readable/usable documentation for technical and non-technical audiences.
•Extensive experience with documenting standard operating procedures, policies and procedures, software and hardware content, and customer-facing content with the ability to function at high a level and in a wide variety of settings.
•Ability to effectively communicate and collaborate with business partners, subject matter experts, program managers, product experts, and other technically savvy industry personnel to explain technical ideas in user- friendly language.
PROFESSIONAL SKILLS
•Exceptional and proven technical writing and verbal communication skills.
•Ability to edit and format documents following specifications, industry-standard style and writing guidelines, and branding using several types of content management programs.
•Successful at juggling multiple projects and deadlines while staying calm under pressure.
•Extensive knowledge of writing, rewriting, editing, and proofreading technical manuscripts, promotional products, online content, corporate internal publications, and business development deliverables.
•Experience working within both document management systems for document creation and retention and knowledge management systems that capture experience and information for use throughout an organization.
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PROFESSIONAL
EXPERIENCE
Lead Analyst, R&D Medical Technical Writing
Physio-Control
TECHNICAL WRITER/EDITOR
Windows, Xbox, and devices (Surface)
Jan 2015 – June 2019
•Created and maintained Windows, Surface, and Xbox console customer support content for the end-to- end customer experience on the Microsoft website using the Microsoft Manual of Style (MSTP) and other product specific Microsoft style guides.
•Identified and improved low performing Windows and Surface support content using machine learning models and chat transcript analysis with MSEG (Microsoft Engineering Group).
•Organized and drove meetings with subject matter experts and program managers to review the technical accuracy for all new and updated content.
•Project manager and principal content writer/builder for content scripts and dialogs for the Xbox Virtual Assistant chat bot. Responsibilities include:
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Developed the dialog conversational experience in both a diagram format and content management program using HTML and XML.
Analyzed both product data and customer chat data to understand how customers use the product, identify specific questions or problems that the customer needs addressed, and decide when to incorporate new platform features into the product.
Developed, wrote, and maintained the current process for creating, retaining, and analyzing the Virtual Assistant chat data for multi-product and stakeholder use.
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TECHNICAL EDITOR
Microsoft Retail Stores Team, Redmond, WA
Jun 2014 - Dec 2014
Produced Microsoft Retail Store documentation that followed documentation plan requirements and standards.
Obtained technical information from project developers, program managers, product managers, and product support personnel to convert specific feedback into documentation.
Used SharePoint and TFS on Microsoft Visual Studio as a content management system for all documentation creation and editing.
Collaborated with team members to determine documentation needs, build a documentation plan, create the documentation, vet the documentation, and revise the documentation as needed.
Planned, organized, analyzed, and interpreter technical specifications prepared by engineers to determine proper content for documentation.
Wrote user-friendly, original documentation for hardware and software product documentation, which included installation, operation, and maintenance instructions for all Microsoft Retail Store personnel. Validated the functionality of the both the hardware setup and software function in a test environment.
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POLICY AND PROCEDURE TECHNICAL WRITER
343 Industries, Kirkland, WA
Mar 2014 - Jun 2014
Responsible for writing the original Key Management security and operational policies and procedures used as a knowledge base for organizational processes and practice.
Reviewed the policies and procedures for both 343 Industries and Microsoft Studios against the Microsoft Security and MSIT policies to ensure compliance with Microsoft security requirements. Included Microsoft policy standards through extensive research, observation/inspections, and from the interviews of key personal of the organization.
Researched and verified the accuracy of facts in written data by interviewing all levels of personnel at 343 Industries and Microsoft Studios. Made corrections in case of incorrect content within the documents.
Documented the results of new procedures after implementation to show quality improvements.
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TECHNICAL EDITOR 2
Filter Digital, Seattle, WA
Sep 2012 - Apr 2013
Served as Technical Editor 2 for the Office 365 team managing the security and privacy updates to the external facing Office 365 Trust Center web site.
Used technical writing skills and technical understanding of content to communicate highly technical content for both a technical and non-technical audience.
Responsible for the end to end publishing process of the security and privacy sections content for the Office 365 Trust Center webs site.
Responsible for the Content Management process of content including the project plan, project schedule, and OARP (Owner, Reviewer, Approver, and Participant) for the fiscal year.
Coordinated and drove the review of documents with an extended core team using SharePoint. Responsible for obtaining the sign-off from stakeholders for all new and updated content.
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Jun 2012 - Sep 2012
TECHNICAL WRITER/EDITOR
Entirenet, Redmond, WA
Jan 1999 - Nov 2007
Wrote and edited technical documentation online for structure, style, organization, and technical accuracy for Microsoft Knowledge Base articles using a content management program using HTML and XML.
Used excellent verbal and writing skills to edit complex technical information for both non-technical and technical audiences.
Performed content editing on end-user articles that to ensure that the articles were grammatically and logically correct and were within the Dynamic Web page criteria of the Microsoft Knowledge Base web site and Microsoft Manual of Style (MSTP).
Reproduced the steps of the article to verify technical accuracy, and to ensure that the article was written for the proper end-user audience (either for developers or for end-users that are new to the product) before publishing the article.
Responsible for the Content Management process for security releases and version updates for all editors working on the Microsoft Office Knowledge Base articles.
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EDUCATION
B.A., (Physical Anthropology) 1993 University of Nevada-Las Vegas
CONTENT EDITOR
Filter Digital, Seattle, WA
•Edited customer-focused content, including the Xbox user interface and hardware print manuals.
•Edited consumer-space focusing on the end-to-end customer experience.
•Maintained quality standards for a casual, entertainment-oriented voice and style.
•Edited the Xbox user interface text for grammar, terminology, word choice, consistency, tone, and flow using the Microsoft Manual of Style (MSTP).
•Edited hardware print manuals for grammar, clarity, and consistency by using excellent technical writing, and verbal skills.
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