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Jacquie Rich - Freelance Bookkeeping & Billing
0
Kudos
3.5
2 Skills
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Description not provided
Toronto, Ontario, Canada

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Anders Nielsen - Freelance Comedy Writing & Journalistic Writing
0
Kudos
3.5
2 Skills
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Anders J. Nielsen is a freelance writer and comedian based in Portland, ME. He has experience writing for established journalism and arts magazines (The Bollard, Discover Copenhagen), and extensive training in comedic writing, performance and production (UCB Theater, Various online work). Anders also has extensive experience in events and project management. His varied background makes him the perfect candidate for any organization looking for fresh and new writing techniques, novel ideas and a self-motivated individual to get things done. The Bollard, Portland, ME Summer 2011 – Spring 2013 Writer •Managed online content •Wrote live show and album reviews •Authored cover stories •Compiled and investigated research Upright Citizens Brigade, New York, NY Summer 2012 – Summer 2013 Sales •Booked Touring Comedy Co. •Managed online accounts •Developed relationships with clients •Participated in cold calling and email campaign SPACE Gallery, Portland, ME Winter 2010 – Winter 2011 Events Assistant •Authored press releases •Planned events •Managed day-of operations •Programmed website •Blogged events and new artists Portland Performing Arts Festival, Portland, ME Winter 2012 – Summer 2012 Events Manager •Organized and compiled advertising •Managed main events •Set-up for events Student Activities Council, Connecticut College Fall 2011-Spring 2012 Chair of Events Series ` •Set up and managed events • Booked bands and artists for Friday night events •Organized student musicians into cover band series •Managed Events Committee • Planned, booked and managed day long music festival Proficiency: • Office Management, Scheduling, and Filing. Highly Organized and Energetic. • Highly computer literate including but not limited to: MS Word, Excel, PowerPoint, and Adobe • Excellent customer service skills including Sales, Marketing, Client Management and Letter Writing
Portland, Maine, United States
Tom Merke - Freelance Comic Art & Illustration
5
Kudos
5.0
2 Skills
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Rate/Hr
I'm an industrial designer with over 6 years of practical experience. From CAD drafting in 3D packages to isometric technical illustrations I can help you with everything. I also have extensive experience in storyboarding and illustrating comic books.
Sydney, New South Wales, Australia
Linda Francis - Freelance Editing & Secretarial
0
Kudos
4.5
2 Skills
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LINDA FRANCIS 317 Franklin Avenue, Apt. A • Mt. Vernon, NY 10553 • meadel25@yahoo.com • (646) 463-9088 Actively seeking a professional position with an organization/company accepting a talented and motivated employee with strong abilities to effectively support and contribute to desired goals and objectives SUMMARY OF QUALIFICATIONS • More than 6 years of administrative experience, successfully utilizing time management and analytical skills in fast-paced environments • Possesses Bachelor of Science in Paralegal Studies degree • Demonstrates ability to research information and draft documents with high attention to detail • Expertise in assisting with organizing training programs, optimizing business accomplishments • Ability to build immediate rapport with contacts, maintaining high degree of confidentiality and ensuring service satisfaction • Proficient in Microsoft Word 2003 and 2007, Excel, PowerPoint, Outlook, Adobe, Pronto, DTE, Elite Search, Timeslips, T&E expense management, DeltaView, Lotus Notes, PC Doc, GroupWise, Hummingbird, WorkShare, Wave Pedal transcription, WebView Interwoven, iManage, Ceridian, Billback, Workflow and LexisNexis EDUCATION AND TRAINING BACHELOR OF SCIENCE IN PARALEGAL STUDIES 2010 KAPLAN UNIVERSITY Davenport, FL ASSOCIATES OF APPLIED SCIENCE IN OFFICE TECHNOLOGY 2001 MONROE COLLEGE Bronx, NY PROFESSIONAL EXPERIENCE ADMINISTRATIVE ASSISTANT/TRAINING FACILITATOR May 2009-March 2011 NATIONAL DEVELOPMENT AND RESEARCH INSTITUTES, INC. New York, NY Non-profit research and educational organization, founded in 1967, that works towards advancing scientific knowledge in the medical field and other industries • Instrumental in developing 500 page training manual, researching information and providing comprehensive document with consistent formatting; Create and distribute marketing flyers used to advertise new trainings. • Update and maintain company website and client database to ensure current information available to public, handled telephone inquiries regarding training and CASAC requirements; reconcile inconsistencies involving vendors, course materials and/or scheduling dates. • Extensive knowledge of medical terminology; managing electronic files; knowledge of HIPPA and Privacy Act; extract data from data base; Obtain additional information from other state agencies data base. • Coordinate office work to ensure efficient workflow as well as assisting to maintain flow of office. • Establish and maintain physical files of training and training material as well as state budgeting information; Prepare notices and training advertisements for the training institute. LEGAL SECRETARY June 2007-November 2008 WHITE & CASE LLP New York, NY International law firm, founded in 1901, that assists public and privately held companies, financial institutions, governments and state-owned entities • Assisted 1 partner and 4 associates specializing in mergers and acquisitions, ensuring professionalism and discretion, Created PowerPoint presentations for inclusion with merger and acquisition agreements, meeting 100% of deadlines • Reformatted international documents to company standard format, resulting in increasing user-friendliness of documents; Edited documents including share purchase agreements, stockholder agreements, letters of intent and other restructuring agreements for attorney use, maintaining high attention to detail; Coordinated complex domestic and international travel arrangements weekly, conference scheduling; entering attorney time; editing monthly billing prior to remittance for payment; creating customer accounts for air travel, hotel accommodations and car rentals ADMINISTRATIVE ASSISTANT/LEGAL SECRETARY January 2005-August 2006 COVINGTON & BURLING LLP New York, NY International law firm, founded in 1919, has more than 750 lawyers in 8 offices to assist clients with legal needs • Diligently assisted 1 partner and 2 associates specializing in intellectual property, litigation and corporate law • Compiled and organized Securities and Exchange Commission (SEC) and due diligence documents, working collaboratively with records department • Thoroughly reviewed monthly bills, expense reports and timesheets to identify and resolve discrepancies before final submission SENIOR ADMINISTRATIVE ASSISTANT July 2000-November 2004 JP MORGAN CHASE BANK New York, NY Financial services firm, headquartered in New York City, that has operations in more than 60 countries to serve consumers, corporations, institutions and governments • Assisted in multiple legal areas including intellectual property and litigation, thoroughly preparing documentation for attorney use in timely manner • Communicated with attorneys each week to collect all receipts to accurately complete expense reports, proactively contacting vendors when necessary to obtain copies of missing receipts • Maintained scheduling of conference calls, depositions and meetings, avoiding conflicting schedules by utilizing organizational skills
United States
Lynn Cleary - Freelance Book Illustration & Digital Art
6
Kudos
5.0
2 Skills
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Rate/Hr
Hello, My name is Lynn and I am Illustrator. I specialize in narrative-based illustration as well as character design and portraiture. To tell you a little bit about myself, I have studied art and illustration for six years and will be completing my BA Illustration this year. I have experience in using both digital and traditional mediums as well as an in-depth background using design tools: Illustrator, Photoshop, InDesign. I have a great love for telling story's and making characters come to life using my experience, versatility and passion.
Ottawa, Ontario, Canada
Dennis Sterne - Freelance Brochure Design & Magazine Design
0
Kudos
5.0
2 Skills
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Rate/Hr
Fashion and Lifestyle Editorial Art Director with Conde Nast experience and great communication skills. Addition art skills include illustration and photography to high commercial level. Also worked on promotions and advertising for luxury brands.
United Kingdom
Darren Lewis - Freelance Digital Art & Storyboarding
15
Kudos
5.0
2 Skills
$15
Rate/Hr
I am an experienced and skilled film, television and games Computer Animator/Concept Artist with over ten years industry experience, working for a number of well-established companies. I have worked on several notable computer games, such as Harry Potter, Star Wars, Jambo and Monopoly. I have a good working knowledge of the process of Computer Games production and my specific professional experience encompasses 3D animation, 2D character and background design, storyboarding, animatics, rigging and skinning.
Birmingham UK, West Midlands, United Kingdom
Dallas Thomas - Freelance Quality Assurance & Consulting
0
Kudos
3.0
2 Skills
$90
Rate/Hr
Dallas L. Thomas, RAC, MHA, MPA, SSYB, Certified Lead Auditor West Palm Beach Area, Florida, USA Mobile/Work Phone +1 801 613 2601 Email: thomas.regulatory@gmail.com Global Regulatory Affairs & Quality/Compliance/Auditing PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing professional with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510(k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regulatory Affairs Certification (RAC). Certified Lead Auditor for ISO 13485. Certified Six Sigma Yellow Belt. Experience working with multi-disciplinary teams. Proven organization and time management skills with ability to multi-task under stress. Exposure to national & international regulatory standards such as GMPs, ISO 13485, ISO 9001, QSRs, 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185, and MDD 93/42/EEC, among others. Ability to work well under pressure and handle multiple projects and meet multiple deadlines, while managing priorities accordingly. Prior team building/management and supervisory experience. 2 master’s degrees (Health Administration & Public Administration). Fluent in Spanish and Portuguese. Experience: Chemular (subsequently via Hudson Scientific), Michigan - Quality and Regulatory Consultant (July 2016-Present) ? On Site Quality Management Systems auditing, as lead auditor. ? First time implementation of a QMS ? Prepared client companies for ISO Certification Audits ? Assess for Non-Conformities of Quality Management Systems requirements and propose corrective and preventive actions for compliance. ? Client Training on Management Review, External Audit Preparation, All Employee Training on Quality Management Systems ? Technical File Preparation Axiom Medical, California- Remote Member of UDI Support Team (September 2016) via consulting firm partner company ? Unique Device Identification (UDI) associate consultant ? Assist with Gathering and Uploading data to FDA GUDID before deadline US Ophthalmic, Miami, FL - Quality and Regulatory Consultant (June 2016-Present) ? Unique Device Identification (UDI) general guidance to client ? Quality Management Systems preparation for 13485 Certification ? First time implementation of a QMS ? Revision to QMS for preparation of 13485 Certification Face View Mask, Inc., Virginia - Remote Regulatory Affairs Consultant (December 2015-January 2016) via consulting firm partner company ? Premarket Regulatory Assessments ? Label reviews for conformance to US and EU markets ? New Technical File and first time CE Mark for Radiographic Ophthalmology Device ? Review of Applicable Guidance Documents ? Classification of Devices for FDA submission pathway and using rules from MDD 93/42/EEC Acuderm Inc., Fort Lauderdale, FL- Regulatory Affairs Consultant (March 2016-Present) via consulting firm partner company ? Project manager for team of 5 for EU Technical File Updates and Remediation and response to Notified Body major non-conformities, minor non-conformities and observations. ? Remediating various Tech File deficiencies from notified body audit including Risk Management, Essential Requirements Checklist, Post Market Surveillance, and Labeling ? Coordinated remediation of deficiencies with SMEs in Verification and Validation, Design Controls, Clinical Evaluation Zimmer Biomet, Palm Beach Gardens, FL- Senior Regulatory Affairs Specialist (January 2016 –Present) ? Preparation and member of ANVISA (Brazilian Agency) GMP Audit Team ? Certified Lead Internal Auditor for ISO 13485 Scope and Internal audits of Quality System ? New Product Development Regulatory Representative responsible for regulatory pathway assessments for FDA 510(k), Letters to File, EU CE Mark Technical Files, Health Canada new applications and amendments. ? Participate as representative in the change control process for proposed changes to product design, supplier and raw material changes, labeling changes. ? Notification of changes to Global counterparts for regulatory impact assessment of changes in all geographies and providing ? Regulatory affairs projects and submissions for class I and II US FDA 510(k) support and Letters to File, Health Canada Submissions (Class I, II, III, and IV) CE Mark (Class I, II and III) and notified body communications. ? EU Technical File Updates and Maintenance and preparation for notified body audit. ? Internal Auditor of the Quality Management Systems per 21 CFR 820 and associated regulations and auditing of multiple internal departments. ? Participated as company audit scribe and crucial audit team member in multiple external audits (Notified Body, Microbiology, FDA prep) ? Regulatory Affairs Database creation of records and maintenance in Oracle, Discoverer, and Application Express Interface ? Creator of online web interface tracker for global regulatory project and task requests from global and internal contacts for internal prioritization. ? Continued support of Latin America geographies as needed. Zimmer Biomet (after merger), Palm Beach Gardens, FL- Senior International Regulatory Affairs Specialist (January 2015 –January 2016) ? Moved from consultant to employee and continued work on items below, along with additional depth and responsibility in those areas. Biomet, Palm Beach Gardens, FL- Regulatory Affairs Consultant (July 2014 –January 2015) ? Device Registrations and Device Renewals and tracking in Latin America geographies. ? Internal training to applicable SOPs, protocols, and procedures. ? Assist with Product Change Notifications to global geographies as needed. ? Fixing multiple registration errors done by Ministries of Health and prior internal employee generations. ? Set up registration records of current product registrations for future reference and organization. ? Obtained dozens of first time registrations and dozens of renewals/product sustaining work across the entire Latin America geography and a variety of MOH’s. ? Interfacing with regulatory contacts within company subsidiaries and third party contract distributors in Portuguese and Spanish on a daily basis in both written and spoken formats. ? Researched and translated native-language Latin America regulations to implement a compliant regulatory strategy in harmony with COFEPRIS (MX), ANVISA (BR), DNM (El Salvador), INVIMA (Colombia), DIGEMID (Peru), and ANMAT (Argentina) among others. ? Due diligence to in-country standards and regulations for labeling, pre-market authorization and clearance as well as post-market compliance to in-country requirements. C.R. Bard, Inc., Bard Access Systems Division, Salt Lake City, UT-International Regulatory Affairs Specialist (October 2013 –July 2014) ? Obtained RAC-Certification (EU) for the scope of all regulated sectors (Pharmaceuticals, Medical Devices, IVDs, etc.) after proven self-study and examination of the Regulatory Affairs Professionals Society (RAPS). ? Successfully drove, coordinated, and completed multiple International Dossier Submissions for First Time Registrations of various product families in the markets of Asia, Latin America, EEMEA, and other core geographies. ? Successfully CE-Marked many products according to the Medical Devices Directive 93/42/EEC including direct responsibility for the Essential Requirements Matrix and the Declaration of Conformity. ? Participated in relevant phases of design control activities as needed. ? Maintained updates to CE technical files for compliance purposes. ? Notified global regulatory counterparts on changes to product design, IFUs, labels, sterilization, etc. ? Maintained direct contact with company representatives around the globe in Asia, Latin America, EEMEA, Europe and Australia. ? RA Representative and Portuguese Translator for Brazil Deep Dive Team in Sao Paulo and Curitiba, Brazil ? Portuguese Translator for Brazilian Nurses at Infusion Nurses Society (INS) Event 2014 in Phoenix, AZ. C.R. Bard, Inc., Bard Access Systems Division, Salt Lake City, UT-International Regulatory Affairs Associate (January 2012 – September 2013) ? Trained and acted in Capacity of Internal Auditor including training to 21 CFR 820, FDA Quality System Regulations, and ISO 13485. Revised department procedures. Participated in label audits and audits of other departments as called upon by Lead Auditors. ? Successfully drove and completed multiple International Dossier Submissions for First Time Registrations of various product families in the markets of Asia, Latin America, EEMEA, and other core geographies. ? Successfully CE-Marked products according to the Medical Devices Directive 93/42/EEC including the Essential Requirements Matrix and the sign off of CE Declaration of Conformity by management. ? Dozens of international regulatory submissions and a signatory to reformatting/updating/maintaining EU Technical Files and Design Dossiers including, DOC, ERC, and compilation of additional appendices of supporting documents in areas of QMS, Risk Management, Sterilization, Biocompatibility, Design Verification and Validation, Shelf Life, Labeling, etc. in remediation and preparation for a notified body audits. Utilized GHTF (now IMDRF), Team NB Med, and MDD 93/42EEC guidance documents and templates to feed internal formatting and SOPs. ? Participated in relevant phases of design control activities as needed. ? Maintained updates to CE technical files for compliance purposes. ? Notified global regulatory counterparts on changes to product design, IFUs, labels, sterilization, etc. ? Maintained direct contact with company representatives around the globe in Asia, Latin America, EEMEA, and Australia. ? Efficiently assessed product modifications and updates to labeling and IFUs in order to maintain regulatory compliance and approve allowed changes. ? Worked directly with our Portuguese and Spanish speaking counterparts in Brazil and Mexico in order to ensure efficient and productive product submissions, renewals, and sustaining of currently registered products. Lead conference calls with Latin America Regulatory contacts in Portuguese and Spanish. ? Worked directly with multi-disciplinary teams in order to provide regulatory assessment on product modifications, upgrades, label changes, IFU modifications, etc. ? Interfaced directly with cross-functional departments in order to acquire relevant regulatory information from R&D, Quality, Biocompatibility, and Sterilization Departments in order to supply to company business centers worldwide. ? Trained all immediate team members on International Product Submission Dossiers per appropriate corporate and division-level protocol, as I was a founding member of the International RA team. ? Responded to registration deficiencies from ANVISA (Brazil), COFEPRIS (Mexico), CFDA (China), MHLW (Japan), and various competent authorities in Europe. ? Supported hospital tender/contract requests for regulatory information globally. ? Received, prioritized, and concluded hundreds of International Regulatory requests related to implantable port-catheter products such as document requests, hospital tenders, and additional registration activities. ? Supervised and trained two intern staff members who reported directly to me for their projects and workload. ? Participant on corporate-wide committee to update the corporate international dossier protocol. C.R. Bard, Inc., Bard Access Systems Division, Salt Lake City, UT-Domestic U.S. Regulatory Affairs Intern (April 2011 – December 2011) ? Regulatory representative on US domestic team for Implantable Ports and Catheters for both power-injectable and non-power injectable ports, port kit components and accessories, as well as assisting with regulatory device labeling and packaging requirements for Corporate-level, FDA 510(k) submission support, and compliance to the Food Drug and Cosmetics Act, and 21 CFR 820. ? Regulatory support for both new product development (NPD) and sustaining existing products with their respective modifications (notes to file/notification of change). ? Assisting in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepared required documentation as needed. ? Supporting coordination and review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA. ? Confirming translations of international regulatory/labeling/marketing documents in the Portuguese and Spanish languages prior to submission. ? Supporting the review of proposals for new product development as well as modification of current medical devices in order to meet regulatory submissions. ? Representing regulatory affairs on product development teams to provide assistance with respect to regulatory requirements and strategy. ? Assisting in development of new product instructions for use/promotional and advertising material including labels and labeling. Reviewing product labeling for compliance with medical device regulations and Division/Corporate Policies. ? Providing marketed product regulatory support for change management activities, product registrations, and business improvement activities. ? Drafting and submitting notifications of change to notified bodies/authorized representatives for international regulatory submissions to BSI, Medicon, and corporate-level international business centers. Compiling support documentation for said notifications of change. ? Verified and updated hundreds of data points for product-line specific regulatory database in order to maintain current and accurate regulatory data from the past and present. ? Acting as support in tracking engineering change notices (modifications to products) in order to verify appropriate regulatory implications in relevant domestic and international markets. Deseret Industries, West Valley City, UT- Department Manager/Job Coach Trainer (June 2008 – Jan 2012) ? Supervised up to 21 associates concurrently, across 3 departments to reach production and sales goals. ? Coordinated and collaborated on associate hours budgeting to reach Total Budgeted Operations goals. ? Ensured quality standards and policy alignment in production areas. ? Resolved customer issues and concerns and provided 100% customer satisfaction. ? Completed several key company goals regarding new pilot program implementation. ? Utilized MS Office Suite for company operations, forms, schedules, tracking goals, and evaluating product sales. EDUCATION: University of Utah-Salt Lake City, UT ? Masters of Health Administration, David Eccles School of Business, 2010-2013 (Emphasis in device regulatory affairs) ? Masters of Public Administration, Center For Public Policy and Administration, 2010-2013 (Emphasis in device regulatory affairs) Brigham Young University-Provo, UT ? Bachelors of Science in Human Development, 2005-2008 Utah State University-Logan, UT ? General Education Coursework, 2004-2005 (Portuguese Coursework) (Spanish Coursework) ADDITIONAL TRAINING: ? FDA Design Controls, Palm Beach Gardens, FL, 2014 ? BSI Medical Device CE Marking Seminar, San Diego, CA, 2012 ? FDLI Brazil Conference on Medical Device Registration, São Paulo Brazil, 2012 ? Latin America Life Science Regulatory Affairs, New Orleans, LA 2013 ? Crucial Confrontations Leadership Training, Salt Lake City, UT 2014 ? Bard Brazil Deep Dive, RA & Portuguese Translator, 2014, São Paulo & Curitiba, Brazil. ? RAC, Regulatory Affairs Certification—RAPS (Regulatory Affairs Professionals Soc) May 2014 ? ADVAMED 2015, International Committee Member, San Diego, CA October 2015 ? Lead Auditor Certificate (ISO 13485) issued by BSI, Palm Beach Gardens, FL July 2016 ? Internal Auditor Certificate (ISO 13485) issued by BSI, Palm Beach Gardens, FL July 2016 ? ISO 13485 Training Certificate issued by BSI, Palm Beach Gardens, FL July 2016 ? Six Sigma Yellow Belt Certificate issued October 2016 COMPUTER SKILLS: ? PC & Mac literate ? Proficient in Microsoft Office Suite Software (Word, Excel, PowerPoint, Outlook, Access Database) ? PDF Manipulation, editing, and data extraction in Adobe Acrobat ? Additional Software Experience: MFG Pro, Qumas, Docushare, Final Cut Pro, Master Control, SharePoint, Oracle Database, ETQ Reliance, TipQA, InfoPath, Application Express and Oracle Discoverer. LANGUAGES: ? Speaks, reads, writes & translates Professional level Portuguese fluently with on the Job Translation Experience. ? Speaks, reads, writes and translates Spanish with high professional fluency. LIVING ABROAD: ? Lived abroad in Sao Paulo, Brazil for 2 years, establishing Portuguese fluency and leveraging to subsequent Spanish fluency. REFERENCES: Additional References Available Upon Request
Jupiter, Florida, United States
Stacey Brown - Freelance Editing & Writing
0
Kudos
4.0
2 Skills
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Rate/Hr
As a certified and experienced secondary English instructor, I have extensive knowledge of writing, literature, and grammar. I am a skilled writer and editor of technical, informative, descriptive, research, or creative compositions. I also have a Masters degree in Literature.
Simpsonville, South Carolina, United States
Mark Graham - Freelance Article Writing & Children's Book Writing
1
Kudos
3.0
2 Skills
$14
Rate/Hr
I have several degrees from Geneva College. The degrees are as follows; one is a general degree with courses dealing with Early Childhood/Elementary Education, one in Human Services, a diploma in Practical Nursing. I even have some graduate work in Counseling. The bulk of the graduate courses were mainly dealing with children and adolescents. I have been working as a Licensed Practical Nurse for the last 12 years with the geriatric population doing general nursing care and doing activity groups when possible. I also worked as a Nursing Assistant for 2 years prior to being a practical nurse. I also have some experience working with children with emotional disturburances when I worked for a semester as a long-term substitute teacher assistant. I also worked as a Substitute Assistant Group Supervisor for a Head Start Program over a few years when needed. I am currently trying to get several children's books published that deal with learning basic skills (academic and social skills). I am also a published poet.
Ellwood City, Pennsylvania, United States