Quality Assurance Medical

Cliff Scheer

**** ***** ****** ***** ( Raleigh, NC 27613 ( Home: 919-***-****

( E-Mail: *******@**.**.***

Objective: To secure a position as a senior-level technical/medical

writer/editor, utilizing expert skills in compliance, software

development life-cycle (SDLC), computer system validation (CSV),

quality assurance, instructional design, and training.

Experience:

ClearPoint Learning Systems - Senior Content Developer/Instructional

Designer

October 2008 - Present

. Create instructional materials for the life sciences industry across a

broad range of subject areas, including: pharmaceutical, clinical and

scientific research, medical devices, managed care, compliance, business

acumen, and marketing.

. Collaborate with client stakeholders, subject matter experts, and cross-

functional leads to identify training needs, define learning objectives,

and develop course outlines that drive the creation of instructional

material.

. Ensure that content is accurate, credible, clear, instructionally sound,

and consistent with the client's stated training need.

. Develop source content to support program objectives by synthesizing

content from research, interviews with subject matter experts,

prescribing information (PI) data, and existing client-provided

materials.

. Make complex content easy for the intended audience to understand by

varying writing style and level of complexity to accommodate the learner

profile.

. Translate source content for instructional materials into illustrations,

examples, patient cases, and scenarios.

. Write material for delivery via e-learning, instructor-led training

(ILT), virtual workshops, mobile and web platforms.

. Collaborate with team members to ensure that deliverables meet client

expectations, are within stated timelines and budgets, and adhere to

style guidelines.

. Follow development processes and production methodologies.

. Utilize proprietary MS Word scripting tools to design interactivity,

graphical treatments, and animations for e-learning courses.

. Research, verify, and document all medical and technical references used

in course content.

. Serve as a content team lead on projects composed of freelance writers

and designers.

Teleflex Medical - Contract Sr. Compliance Specialist/Technical Writer

and Editor

August 2007 - December 2008

. Provide advanced technical writing/editing services for a global, multi-

disciplinary, GMP-regulated environment, documenting processes and

procedures for the design, engineering, validation, facility operations,

production, QC/QA, and distribution of medical devices.

. Perform process mapping (consolidating input from multiple sites for a

single generic process), create or revise standard operating procedures

(SOPs), Work Instructions, forms, and templates (related to process,

quality, and equipment) at the corporate level, then revise documents at

the local plant level (in the United States, Mexico, Ireland, and Czech

Republic) to align with corporate documents.

. Create SOPs, complex technical forms, and data standards documenting SAP

and non-SAP compliance processes.

. Review existing SOPs to ensure compliance with regulatory requirements,

clarity of language, and consistency of format, then revise accordingly.

Cliff Scheer

Page 2

Experience (Continued)

. Create training materials for CSV, SDLC, GxP, FDA 21 CFR Part 11,

Sarbanes-Oxley (SOX), and audit readiness.

. Use document management system to manage the creation, review, revision,

and archival cycles of controlled documents.

Quintiles, Inc. - Senior Writer/Editor/Business Analyst - April 2001 -

August 2007

Senior Technical Communication Specialist - October

1993 - April 2001

. Provide advanced process re-engineering, technical writing/editing,

business analysis, compliance, and quality management services for a

global contract research organization engaged in the discovery,

development, manufacturing, and marketing of pharmaceutical products and

services.

. Create corporate and departmental style guides.

. Edit and proofread deliverables to align with industry, corporate, and

client style guidelines.

. Lead or participate in global task forces to evaluate regulatory

requirements for validation activities, and create a program of

procedures and deliverables that interpret regulations appropriate for

the enterprise.

. Ensure compliance to SDLC activities and required deliverables, and

prepare corrective action plans (CAPs) in response to internal and

external QA audit findings.

. Analyze and model existing processes, and document written procedures and

training modules that emphasize process re-engineering and quality

improvement to ensure that methodology is consistent across projects and

compliant with corporate policies, criteria, and standards (e.g., FDA 21

CFR Part 11, GxP, Sarbanes-Oxley, GAMP).

. Participate in the structuring of a strategic partnership with an off-

shore technical resource in Bangalore, India; mentor off-shore personnel

in the creation of software development documentation, and in the conduct

of IQ/OQ/PQ testing for Quintiles.

. Create and maintain audit finding/response and issue/incident databases.

. Plan and coordinate document design and development for local, regional,

or transnational use (including the creation of SOPs, Work Instructions,

Project Instructions, and other controlled documents) that adhere to

regulatory guidelines.

. Perform internal reviews/audits of required documentation deliverables in

support of the SDLC (including Requirement Specifications, Functional

Specifications, IQ/OQ/PQ, use cases, testing summary reports, records of

system change requests, Implementation Plans, Retirement Plans).

. Edit/proofread clinical documents in preparation for submission to

regulatory agencies.

. Prepare training materials and conduct training classes in CSV and SDLC.

. Plan, coordinate, and document departmental and site Business Continuity

and Disaster Recovery Plans.

. Provide leadership to the global Scientific/Clinical Operations business

units in the areas of process engineering, process improvement, technical

documentation, and compliance/QA consultation for CSV procedures.

. Create a variety of internal communications, including white papers,

corporate newsletter, intranet pages, SharePoint sites, PowerPoint

presentations, and training materials.

Ciba Corning Diagnostics - Contract Senior Technical Writer/Editor - 1990-

1993

Research, create, edit, proofread, and format technical manuals for medical

diagnostic instrumentation and related software for the health care

industry.

Cliff Scheer

Page 3

Experience (Continued)

PSI Institute of Cleveland - President - 1988-1990

Chief administrator for a proprietary school offering accredited training

in computer and electronics industries. Create and edit all corporate

communications, including seminar materials, newsletters, and grant

proposals. Research and develop promotional strategies and marketing

literature.

Dextralog-Scantex Corporation - Vice President & General Manager - 1987-

1988

Chief administrator for national branch of international company that

designs and markets computer-integrated manufacturing systems.

Impact Technologies Group, Inc. - Vice President of Software Marketing -

1984-1987

Direct all communications efforts for this software design firm. Create

user documentation, press releases, advertising copy, scripts for video

presentations, and newsletters. Represent company at trade conventions,

demonstrating software products and new technology.

Technical Skills

Microsoft Office RefWorks

MS VISIO SharePoint

Adobe Acrobat InfoStrength Smart Enterprise Suite

Adobe PhotoDeluxe Lectora

Multiple desktop Flash

publishing packages ClinTrial

Multiple online help Oracle Clinical

packages Corel Word Perfect

Articulate Ability to adapt and quickly learn

Captivate new applications

Education

University of North Carolina at Chapel Hill

B.A. - Speech Communication

American Language School, Vienna, Austria

Courses in German and French languages and history

Professional Affiliations

American Medical Writers Association - Member since 1995

International Institute of Business Analysis - Member since 2006

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