Anne Schier
9 Dan Drive Glenmoore, PA 610-458-9847
Experienced Documentation Professional skilled in creating content
for healthcare and pharmaceutical industries
SUMMARY OF QUALIFICATIONS
- 15 years experience creating and publishingstandard operating procedures (SOPs), regulated documents, reference, implementation, controlled document templates, training & sales material
- Excel at working with subject-matter experts to gather information, identify relevant data and audiences, and writing documents that are clear and user friendly
- Superior communication, interview, and presentation abilities
- Trained in Drug Development for IT, Current Good Manufacturing Practice (cGMP), and IT Regulatory Compliance
- Trained in preparation of INDs, NDAs, BLAs, ANDAs, Post-approval supplements
TECHNICAL SKILLS
- MS Office products - Word, Project, Visio, PowerPoint, Excel, Outlook
- Collaboration tools - Lotus Notes email database tools, Sharepoint
- Web conferencing tools - Sametime, MS Office Communicator
- Electronic document management systems- Clearcase, Documentum, Author-it
- Defect tracking tools - Mercury TestDirector, Rational ClearQuest
- Authoring/Publishing tools - Arbortext, RoboHelp, Adobe Acrobat Writer, Author-it
EMPLOYMENT HISTORY
Technical Writer(contract assignment) 6/2010-present
GlaxoSmithKline, Inc. King of Prussia, PA
- Work with IT Technical Leads and Program Managers to create Design Specifications, System Requirements, and Support Profiles using iQMS templates and processes for validated systems
- Ensure documentation complies with Sarbanes-Oxley standards
- Maintain document library in Documentum
Senior Technical Writer 1/2010-6/2010
MEDecision, Inc. Wayne, PA
- Research, write and publish user manuals, installation manuals, help documents, use cases, etc.
- Research, analyze and recommend authoring and content management product for department-wide implementation
- Participate in all phases of the Agile development life cycle to determine document content and user requirements
- Active member of Corporate Wellness Committee
- Team Lead for Corporate Go Green Initiative
Technical Analyst (contract assignment) 11/2008-4//2009
GlaxoSmithKline, Inc. King of Prussia, PA
- Documented data migration plans, including test plans, dependencies, contingency plans, startup/shutdown procedures, installation/backout procedures, SOPs usingiQMS controlled document templates
- Interviewed subject matter experts within Drug Discovery IT
- Maintained document library in Documentum
- Archived regulated documents
Communications Analyst(contract assignment) 4/2008-8/2008
GlaxoSmithKline, Inc. King of Prussia, PA
- Created monthly effort tracking and metrics reports for leadership team
- Researched, wrote and publishedDrug Discovery news articles on corporate Intranet
- Coordinated web broadcast education sessions for Drug Discovery IT staff
- Managedbusiness-to-business secure connection requests to improve corporate/client collaboration
- Coordinated logistics, presentations & web conferencing for multi-nationaldepartment meetings
Senior Technical Writer 5/1990-10/2007
Siemens Medical Solutions Malvern, PA
- Designed and wrote high quality end-user documentation for a variety of uses, including the following:
- Feature/function overviews for Account Management and New Business Sales team
- SOPs for all phases of installing, configuring, and optimizing complex hospital-wide IT systems
- Procedures for extracting data and creating reports to meet state-specific regulatory reporting requirements
- Software QA and test plans
- Procedures for setting up and maintaining interfaces
- Training, reference and troubleshootingguides
- Trained and mentored new hires, student hires and consultants
- Conducted usability testing to validate procedures
- Performed audience analysis to determine users’ information needs
- Coordinated intra-and inter-departmental projects
Customer Education Specialist 11/1988-4/1990
AFTECH King of Prussia, PA
- Trained customers to use credit union financial software
- Created customer training & reference documentation
- Designed and set up loan software screens
Member Service Representative 9/1986-11/1988
PHILADELPHIA FEDERAL CREDIT UNION Philadelphia, PA
- Cross-trained in all credit union departments
- Explained credit union services, opened accounts, resolved account questions
- Processed loans
- Originated mortgage loan applications
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EDUCATION
- BACHELOR OF SCIENCE – MATHEMATICS - VillanovaUniversity Villanova, PA
- Medical Writing Professional Certification – The Center for Professional Innovation and Education Malvern, PA (In progress)
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