The Judge Group, INC
Client is seeking a Senior Technical Writer to coordinate the development of technical documents supporting new advanced diagnostics product releases in a clinical diagnostics environment. The Senior Technical Writer is responsible for working with subject matter experts to create, write, and edit technical documentation while ensuring compliance with regulatory requirements. The successful candidate will work with QA/Regulatory, IT, and other business partners to identify and implement improvements in the documentation process and streamline content creation. Required documentation will include development, verification, and validation plans, software requirements & specifications, test plans, test reports, and SOPs. This will be a 12 months contracted position with potential for extending the duration. Company reserves the right-to-hire this person as a permanent employee at any time during or after the end of contract. Essential Job Duties: -Work with Bioinformatics, Software Development teams, and other business partners to plan, write, and edit technical documentation for a variety of audiences including SQA, Clinical Quality / Regulatory, Lab Operations, R&D, and IT Operations. -Generate documents that meet appropriate quality standards to support formal validation and operational activities. -Develop and edit Standard Operating Procedures (SOPs), training materials, and user manuals. -Work with business partners to lead and implement improvements to the document creation process and content. -Contribute to the development of test plans -Coordinate and maintain organized records of all supporting materials, document drafts, and versions. Qualifications Requirements: -Five or more years of experience in technical writing of software and system documentation -Experience producing documentation for validated medical systems and providing evidence of compliance with legal, business and regulatory requirements such as FDA 21CFR11, CAP/CLIA, or ISO 15189 -Bachelor’s degree, preferably in Technical Writing, Communications, Information Technology, Engineering, or Science -Background knowledge of Molecular Biology or Molecular Genetics -Excellent written and verbal communication skills -Strong attention to detail -Proficiency in MS Office
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The Judge Group, INC
Website : http://www.judge.com/
Working at the crossroads of people and transformative technologies, The Judge Group delivers innovative business solutions - powered by top talent - to help organizations reach their strategic goals and realize opportunities now and in the future. The Judge Group is a leading professional services firm specializing in technology, talent, and learning solutions. Our services are successfully delivered through a network of more than 35 offices in the United States, Canada, China, and India. The Judge Group serves more than 40 Fortune 100 companies and is responsible for the placement of more than 5,000 professionals annually across a wide range of industries.