Kristina (Jensen) Nordhoff
Technical Communicator
Campbell,CA
Summary
Proven results-oriented writing professional adept at producing concise and accurate technical documents. Known for consistently delivering high-quality work under tight deadlines, excelling in guaranteeing the precision and clarity of technical content through effective collaboration with cross-functional teams.
Overview
29
29
years of professional experience
Work History
Senior Scientific Technical Writer, Corporate Project Management, Strategy
CareDx
01.2021 - Current
- Company Overview: Developed and manufactured healthcare solutions for patient and caregiver organ transplant journeys
- Supported creation of regulatory filings, SOPs, requirements specifications, user guides, & other knowledge-based content
- Produced high-quality documentation for clinical workflow applications and other project requests
- Prepared technical documentation per discussions with scientists, meetings with lab personnel, and other sources
- Made complex ideas understandable by translating and consolidating work instructions into SOPs and batch records
- Edited and formatted scientist-authored content in preparation for presentations and publications
- Adjudicated timely reviews and approvals of documentation with project team members and senior management
- Contributed to the creation and improvement of document standards and templates, including in-house style guides
- Developed and manufactured healthcare solutions for patient and caregiver organ transplant journeys
Senior Technical Writer, Regulatory Affairs (Consultant)
Genomic Health (Exact Sciences 2019)
01.2019 - 01.2020
- Company Overview: Developed and manufactured genetic research diagnostics specifically in cancer detection
- Provided technical writing to support for US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) regulatory filings, including document creation, translation, hard-copy compilation, publication, and electronic submissions for cancer diagnostic programs
- Managed process flow of document reviews, adjudication, approvals, publications, and filings
- Created and revised SOPs, regulatory plans, technical files, forms, and other types of documents
- Supported implementation of European Union (EU) In Vitro Diagnostic Regulation (IVDR), cybersecurity, and global regulatory initiatives
- Developed and manufactured genetic research diagnostics specifically in cancer detection
GMP Technical Writer/Editor (Consultant/Contractor)
Biotech GMP Manufacturing
01.2018 - 12.2018
- Company Overview: Provided technical writing and subject matter expertise for development of Quality System SOPs
- Provided technical writing and subject matter expertise for development of Quality System SOPs, Master Batch Records (MBRs), training forms, and other document types to support pre-approval inspection of new biotech GMP facility
- Trained Quality and Manufacturing personnel on new documents, best documentation practices, and training program
- Provided technical writing and subject matter expertise for development of Quality System SOPs
Senior Manager, Quality Systems, Document Change Control
StemCentrx (AbbVie 2016)
01.2012 - 12.2018
- Company Overview: Developed and manufactured therapies to detect and eliminate cancer stem cells
- Developed, implemented, and maintained the QA Document Change Control system and GXP Training program
- Provided technical writing/editing for GXP documents, regulatory filings, and clinical/non-clinical studies
- Supported creation and life-cycle maintenance of documentation to support manufacture, testing, release, label/pack, and shipment of drug substance, drug product, linker-drug, and antibody-drug conjugates (ADCs)
- Supported state, partner, collaborator, and EU Qualified Person (QP) inspections ('war room' activities)
- Performed batch production record (BPR) issuance, BPR lot release reviews, and BPR reconciliation
- Designed, produced, and issued product vial, secondary container, and carton shipping labels
- Prepared genealogy workflows for drug substance, linker-drug, and drug products to enable QA lot release
- Designed and maintained databases and logbooks to support QMS functions (e.g., change control, training)
- Created and maintained corporate style guide for use in creating and editing QA-controlled documents
- Developed and manufactured therapies to detect and eliminate cancer stem cells
Technical Writer/Editor (Consultant/Contractor)
National Parenteral Drug Association (PDA)
01.2011 - 12.2012
- Company Overview: Global provider of science, technology, & regulatory information serving pharma & biopharmaceutical industries
- Performed technical editing, formatting, and proofreading services for PDA Technical Report No
- 54-1: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
- Global provider of science, technology, & regulatory information serving pharma & biopharmaceutical industries
Quality Professional
Genentech (Roche 2009)
01.1996 - 12.2011
- Company Overview: Developed and manufactured medicines to treat patients with serious or life-threatening medical conditions
- Technical Manager, Quality Control (QC) Network Operations
- CMC Clinical Product Quality Steward/Technical Manager, Clinical Product Quality
- Product Quality Technical Manager, Partnership Collaborations (Roche-ExUS), External Quality
- Technical Manager, Project Coordinator, Systems Specialist, Annual Product Reviews (APRs), Global Quality
- Project Lead, Senior Technical Writer/Editor, Trainer, Specialist, QA Documentation, Change Control
- Developed and manufactured medicines to treat patients with serious or life-threatening medical conditions
Education
Bachelors - Biological Sciences
University of Colorado
Drug Development Process - Berkeley Extension
University of California (UC)
Business Improvement Process Certificate - Professional Achievement Award
UC, Santa Cruz Extension
Skills
- Technical Writing and Editing
- Proofreading
- Formatting
- Template creation
- Change control
- Graphic design
- Technical review
- Ability to work autonomously
- Usability
- Accuracy
- Clarity
- Completeness
- Compliance
- Consistency
- Project management
- Organizational skills
- Interpersonal skills
- Communication skills
- Document control systems
- Microsoft Office
- Collaboration tools
- Creating graphics
- Creating visuals
- Instruction writing
- Process documentation
- Product specification
- Style guide creation
- Visual communication
- Desktop publishing
- Template design
- Subject matter expertise
- Software documentation
- User guides
- External team collaboration
- Content editing
- Teamwork and collaboration
- Attention to detail
- Problem-solving abilities
- Multitasking
- Reliability, Adaptability, Flexibility
- Active listening
- Decision-making
- Task prioritization
- Self-motivation
- Time management
- Problem-solving
Professional Associations
- American Medical Writers Association (AMWA), Professional Member, 01/01/24 - Present
- Parenteral Drug Association (PDA), West Coast Chapter, Board Member, Event Logistics Officer, 01/01/05 - 12/31/18
- PDA Letter Publication, Editorial Committee Member and Article Author, 01/01/07 - 12/31/10
Languages
English
Full Professional
English
Native or Bilingual
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Timeline
Senior Scientific Technical Writer, Corporate Project Management, Strategy
CareDx
01.2021 - Current
Senior Technical Writer, Regulatory Affairs (Consultant)
Genomic Health (Exact Sciences 2019)
01.2019 - 01.2020
GMP Technical Writer/Editor (Consultant/Contractor)
Biotech GMP Manufacturing
01.2018 - 12.2018
Senior Manager, Quality Systems, Document Change Control
StemCentrx (AbbVie 2016)
01.2012 - 12.2018
Technical Writer/Editor (Consultant/Contractor)
National Parenteral Drug Association (PDA)
01.2011 - 12.2012
Quality Professional
Genentech (Roche 2009)
01.1996 - 12.2011
Drug Development Process - Berkeley Extension
University of California (UC)
Business Improvement Process Certificate - Professional Achievement Award
UC, Santa Cruz Extension
Bachelors - Biological Sciences
University of Colorado
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