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Amick Brown is seeking an experienced Technical Writer for our direct client.

Location: Sunnyvale, CA

Duration: 5 Months

Estimated pay range: $60 - 75 per hour per client contract and candidate skills, experience and work location.

Job Description

• As a member of the Fluorescence Imaging, LLC organization, The Senior Technical Writer ensures that development, delivery, and maintenance of documentation is consistent and compliant with IFI document SOP and guidelines.
• The Senior Technical Writer produces accurate, clearly presented, consistent documentation per agreed timelines, and requires no day-to-day instruction following general guidance on new assignments and processes.
• The Senior Technical writer should be highly skilled in the development and maintenance of technical documentation, specifically SOPs, WIS (work instructions), protocols, reports, manuscripts, formatting to support drug development disciplines across Clinical development, Manufacturing, Quality Control, Materials Management, Quality Systems.
• This is an on-campus contract position in an office working environment.
• Opportunity for remote work based on delivery of initial request fulfillment.

Roles & Responsibilities

• Plan, write, and edit documents to support Quality System requirements and user groups supporting new drug development of imaging agents activities.
• Collaborate with department team members and with cross-functional team Subject Matter Experts (SMEs) to research and develop content as required to support preparation/formatting of protocols, reports, manuscripts, IND submission sections.
• Plans, writes, edits, and maintains requested documentation (i.e., procedures, work instructions, protocols, reports, etc.)
• Own document creation from inception to completion.
• Format documents per agreed standards/ trouble shoot formatting issues for team.
• Ensure compliance with FDA and regulatory guidelines to GDocP standards for clinical, drug manufacturing and testing.
• Complete documentation control steps to release final documentation. This includes Change Orders in the documentation change control system.
• Participate in process development sub teams as representative for document development.
• Resolve complex issues in creative and effective ways, using skills as an experienced technical communication professional with understanding of industry best practices and team objectives.
• Act as the lead writer on projects and mentor other writers.
• Informs and adheres to policies, procedures, and quality documents. Collaborates with project team members to share knowledge and best practices.
• Uses skills as an experienced technical communication professional with understanding of industry best practices and company objectives to resolve complex issues in creative and effective ways.
• Evaluates, recommends, or develops documentation process and productivity aids. Assist with development of internal writing style guide.

Skills, Experience, Education, & Training

• 8+ years technical writing experience in a pharmaceutical or drug development environment, including documentation for various technical and regulatory audiences.
• Bachelor's degree in communications, professional writing, English, biological/ sciences, or equivalent preferred
• Strong writing and grammar skills in areas of content development and writing style. Analytical ability to grasp and effectively communicate complex scientific and process based concepts.
• Strong organizational and project-management skills with ability to participate in project discussions and manage deliverables per agreed deadlines, set priorities, and manage time effectively.
• Expert skill level using current versions of standard authoring tools, Word, Visio, Excel, Adobe Pro authoring tools required. Direct experience in managing normal.dotm templates, styles and establishing user guidelines required.
• Experience using electronic document management system(s) and thorough understanding of standard document management workflows required. Experience with SmartSolve (formerly Pilgrim) highly desired.
• Working knowledge of Adobe Illustrator, Adobe Photoshop, or equivalent desirable
• Previous experience with drug CMC, clinical trial documentation, QMS in a regulated environment required. Understanding of GxP Quality System concepts and requirements highly desired.
• Professional references and writing examples expected.

Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits:

• Health
• Vision
• Dental
• 401k with company match
• Paid time off.
• Sick Leave
• Long -Term Disability
• Life Insurance
• Wellness & Discount Programs