Kristina J. Email and Phone Number
Ensuring clarity, accuracy, and overall effectiveness when documenting, publishing, or releasing complex documentation.Key Qualifications and Capabilities* Ability to turn complex technical concepts into easily understandable content for intended audiences* Extensive background working remotely with local and international colleagues and clients* Experience delivering high-quality documentation under tight deadlines* Experience with multi-step Quality and Regulatory document publication and filing processes* Significant attention to detail* Excellent written skills in English* Strong working knowledge of Google and Microsoft Office applications and programs* Strong familiarity with and understanding of scientific and technical terminologyServices include the following types of documents and files:* Standard Operating Procedures (SOPs)* Work Instructions (WIs)* Test Methods/Procedures* Forms* Specifications/COAs* Technical Files* Design and Development Plans* Verification/Validation Protocols, Plans, & Reports (IQ/OQ/PQ)* Clinical Study Protocols, Plans, & Reports* Regulatory Filings & Other Agency-Type Submissions* Journal/Article/Manuscript Submissions* Equipment and User Manuals* Training Materials/Job-Aids* End-User Documentation* White Papers* Case Studies* Flowcharts and Graphs* PowerPoint Presentations* Brochures/Pamphlets* Newsletters* Labels (Samples, Product, Carton, Shipping)* Surveys* Databases* Templates
Self
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Self
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Ready For WorkSelf Employed Dec 2024 - PresentSatellite Beach, Florida, Us -
Senior Scientific Technical WriterCaredx, Inc. Feb 2021 - Dec 2024Brisbane, California, UsCorporate Project Management - Technical Writing ServicesProviding technical writing services and support to CareDx portfolio and project teams to enable them to meet the company's mission to improve transplant patient outcomes and support the entire patient journey. CareDx is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. -
Senior Technical Writer/Principal/ConsultantLocal And International Clients Mar 2018 - Feb 2021Provided technical writing and project management services to help global-minded companies bring life-saving products from concept to market.
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Senior Technical Writer, Regulatory Affairs (Consultant)Genomic Health (Acquired By Exact Sciences) May 2019 - Feb 2020• Technical writing to support US and Japan regulatory filings, including document creation, translation, hard copy compilation, publication, and submission• Management of process flow of document reviews, adjudication, approvals, and final publication• Design of workflows, diagrams, schematics, images, and slide decks to support document and product projects• Creation and revision of standard operating procedures (SOPs), regulatory plans, technical files, forms• Support of planning, documentation, and implementation of IVDR, cybersecurity, and global regulatory initiatives• Collaboration with Quality, Manufacturing (MFG), Genomic Sciences, Regulatory, and Research and Development (R&D) teams to meet goals, deliverables, and timelines
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Quality Systems, Document Change Control/Training (Tech Writing On The Side)Stemcentrx (Acquired By Abbvie) Sep 2012 - Mar 2018
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Technical Editor (Consultant)Parenteral Drug Association Nov 2011 - Apr 2012Bethesda, Maryland, Us -
Quality ProfessionalGenentech (Acquired By Roche) Feb 1996 - Apr 2011Technical Manager, QC Network Operations, Corporate Quality, 2009–2011Product Quality Steward/Technical Manager, Clinical Product Quality, 2005–2009Technical Manager, Product Quality, Partnership Collaborations, External Quality 2004–2005Technical Manager/Process Owner, Annual Product Review (APR) Quality System, Global Quality Systems Governance, Metrics & Analysis 2001–2004Project Coordinator, Systems Specialist, Annual Product Reviews (APRs), QA Operations, 2000–2001Project Lead, Technical Writer/Editor, Trainer, QA Change Control, 1998–2000Senior Technical Editor, QA Documentation, Change Control, 1997–1998Specialist/Editor, QA Documentation, Change Control, 1996–1997
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Pda Letter Magazine Editorial Committee MemberParenteral Drug Association (Pda) 2007 - 2010Bethesda, Maryland, Us
Kristina J. Education Details
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University Of Colorado Boulder& Behavioral Science
Frequently Asked Questions about Kristina J.
What company does Kristina J. work for?
Kristina J. works for Self
What is Kristina J.'s role at the current company?
Kristina J.'s current role is Professional Technical Communicator | Document Guru | Scientific/Medical Technical Writing & Editing | Quality & Regulatory | GMP Manufacturing | Research & Development | Software Development | Biotech/Pharma/Devices.
What schools did Kristina J. attend?
Kristina J. attended University Of Colorado Boulder.
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