Medical and Technical Writer and Project Management

Kevin Kirschner

**** ********* ***. acza9o@r.postjobfree.com

Indianapolis, IN 46208 317-***-****

Medical Writer and Project Management Professional

Driven, detail-oriented, and versatile professional with extensive experience writing and editing technical and medical publications. Work with complex subject matter to create clear and concise documentation. Create and communicate project timelines, goals, and status updates while successfully delivering projects from conception to completion. Establish strong team relationships across multiple continents, resolve issues, and consult on projects by working cooperatively and proactively with SMEs and other writers. Ensure content decisions are made in support of style and regulatory guidelines. Received 100-plus hours of training regarding regulatory clinical trial procedures, guidelines, and submissions. Strong ability to manage multiple projects simultaneously. Experience with Lilly systems including Regulus, TrackWise, RAPT, and Leo. Vendor management experience.

Experience

INVENTIV HEALTH CLINICAL ■ Indianapolis, IN

Leading provider of contract drug development services for the pharmaceutical industry.

8/2015–Present

Medical Writer – Global Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls) Insulins

Draft one-off documents such as Regulatory Response documents, Drug Substance and Drug Product Common Technical Documents (CTDs), Prior Approval Supplements, Supplement Amendments, Approval/Attest Letters, Drug Master File, variation forms, etc. for all insulin formulations, delivery methods, and products. Update CMC submission modules based on FDA, EMA, or Ministry of Health feedback. Support new submissions by creating lists of the modules that need updating, assisting with the project management tasks, and collaborating with Subject Matter Experts (SMEs) in U.S., Puerto Rico, and Europe to create submission documents. Manage documents in Regulus data repository, including routing them for review, collating comments, making changes based on comments, and getting the documents approved. Create and maintain detailed eCTD submission maps for all updated submissions. Edit new and legacy documents to remove errors, fix formatting, correct headings, etc. Provide status updates and update the CMC Project Tracker tool throughout the cycle of each project.

8/2014-8/2015

Medical Writer and Editor

Complete authoring tasks for the revision of pharmaceutical clinical trial (drug substance, drug product, and finished goods) documents for an IT system transition at Eli Lilly. Create global regulatory submission documents that are consistent with clinical trial documents. Utilize templates to populate specific information. Coordinate with SMEs (chemists and engineers) across multiple business areas to gather source information. Edit and proofread the work of colleagues to ensure technical accuracy. Assist supervisor with project management tasks such as resource allocation, metrics, and planning. Create and implement training documentation.

JOHN WILEY & SONS, INC. ■ Indianapolis, IN

Independent trade and textbook publisher with several thousand employees in the U.S. and abroad.

Editorial Manager 2002–12/31/2013

Manage team of ten editors as well as print and digital projects for the For Dummies brand of books and related products, including Web Design For Dummies and Microsoft Office 2013 For Dummies. Create and edit content for print and digital publications. Review page layouts. Drive team initiatives for development and execution of new digital strategies and products, and develop partnerships and products with partners.

Key Accomplishments:

Managed digital and ebook projects and initiatives, leading to year-on-year digital growth of 100%.

Earned Outstanding Accomplishment Award for managing and editing multiple custom publications for Target Corporation, resulting in total sales over $1M.

Kevin Kirschner

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JOHN WILEY & SONS, INC. ■ (Continued)

Key Accomplishments:

Managed multiple print and digital products related to Windows 7 and Office 2010, enabling team to meet revenue plan in a down year for the industry and earning an Outstanding Accomplishment Award.

Acted as editorial and vendor contact in partnership with Inkling (https://www.inkling.com/) to convert Wiley content into interactive eBooks for iPhone, iPad, Mac, and PC. Worked directly with partner to create the blueprint for the product and to ensure it conformed to For Dummies brand and style guidelines. Selected titles for publication, maintained and communicated schedules.

ROCHE DIAGNOSTICS ■ Indianapolis, IN 2001–2002

Manufacturer and distributor of medical diagnostic devices and products for health care providers, researchers, and consumers with 3,000 employees in Indianapolis. (Assignment through Adecco Technical.)

Technical Writer and Editor

Revised and edited application sheets for reagent assays performed on Roche/Hitachi automated clinical chemistry analyzers. Worked closely with Technical Publications team, Chemistry Support Analysts, Customer Training Product Champions, and Global Labeling Communications Associates to ensure accuracy of technical information. Revised technical documents and InDesign templates to meet departmental standards and corporate identity.

HOWARD W. SAMS, INC. (a Bell Atlantic company) ■ Indianapolis, IN 1998–2001

Custom industrial catalog and trade book publishing company with approximately 100 employees.

Editorial Operations Supervisor

Supervised copy editors, proofreaders, and scanners. Prioritized, coordinated, and expedited technical catalogs through the production cycle. Acted as liaison between editorial and multiple departments. Developed and communicated schedules. Maintained master production schedule while allocating resources and monitoring deadlines. Acted as project manager on editorial initiatives. Created and edited technical content.

Key Accomplishments:

Increased production and annual revenue by creating master schedule and managing resource allocation. This new efficiency eliminated the need for temporary staffers.

Increased product quality by instituting system of checks and reporting as leader of Quality Control initiative.

Technical Skills

Office applications (Word, Excel, PowerPoint, Access, Project), Adobe applications (Acrobat, InDesign, Photoshop), social media, search engine optimization, Constant Contact, content management systems, digital photography, SharePoint. Eli Lilly applications and repositories including RAPT, Leo, and Regulus.

Volunteer Work

Member of the John Wiley and Sons, Inc. Charitable Contribution Committee, which organizes charitable drives and events for local organizations including Second Helpings, Gleaners Food Bank, and Habitat for Humanity.

Education

Bachelor of Arts in Journalism

Indiana University Bloomington, Indiana

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