#147607

Technical Writer

Location:
San Diego, CA
Job Terms:
Temporary
Salary:
$42/hr + Subsidized Benefits
Start date:
05/13/2019
Posted By:
Christina Clark
Date:
05/14/2019

Job Description:

We are seeking a highly motivated Scientific Technical Writer to coordinate the writing, editing, and release of verification and validation documentation to support new product releases for our Diagnostics client in San Diego. Document types will include engineering reports, verification and validation protocols and reports, technical specification documents and engineering design and operational process review summaries. The successful candidate will interface broadly with key SME's and cross functional teams to deliver well-written documentation. 

Job Duties: 
• Collaborate with scientists, manufacturing personnel, and other stakeholders to plan, write, and edit technical documentation supporting design verification, design validation and manufacturing process validation activities 
• Proactively manage document reviews and approvals as per established approval process within project schedule 
• Independently synthesize and describe complex scientific data, and be well versed in scientific terminology, principles, and publishing standards 
• Generate documents that meet appropriate quality standard, to support formal verification and validation activities 
• Work efficiently and accurately in content management systems, adhering to best practices and departmental standards for terminology, content management, and reuse. 
• Coordinate and maintain organized records of all supporting materials, document drafts, and versions 
• Execute on SAP or other ERP systems processing of final documents / finished documentation 
• Quickly learn and apply new tools, processes, and standards. Demonstrate adaptability and forward thinking in the face of technological or organizational change 
• Participate in team meetings as needed. Some meetings may be scheduled up till 6 p.m. to accommodate colleagues in Singapore 

Skills Required: 
• English proficiency and excellent grammatical, writing, and editorial skills are required 
• Ability to edit highly-complex scientific content without changing the meaning 
• Ability to transfer complex, scientific information into user-friendly documentation 
• Must be organized, attentive to detail, service oriented, and dedicated to delivering documents that adhere to ISO and FDA standards 
• Must be able to successfully manage multiple projects from concept to release under tight deadlines while coordinating input from numerous sources- ability to drive results through persuasion 
• Must be comfortable and capable of effectively running cross functional team meetings 

Education and Experience: 
• Bachelor's Required, advanced degree in chemistry, biochemistry, material’s or bioengineering, molecular biology, or genetics preferred 
• 2 to 5 years’ experience as a technical writer in industry, (biotech, medical device, scientific equipment) focused on scientific or regulatory writing or the equivalent 
• Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work 
• Experience writing documentation for RUO, LDT and IVD product development projects 
• Knowledge of design control, quality, and regulatory compliance for the development of medical device and diagnostics products, preferably in the clinical diagnostics and IVD field as well as RUO spaces 
• Experience working on technical submissions to the FDA and/or European Regulatory Agencies 
• Experience with assay characterization and automation reports as well as verification and validation protocols/reports
• Demonstrated ability to thrive in fast-paced, highly interdisciplinary environment with rapidly changing priorities 
• Expert level experience in with Word, Visio, Excel, PowerPoint 
• Experience with SAP and Confluence is strongly preferred 
• Experience establishing a collaborative document creation methodology preferred