wowJobs | Senior Technical Writer | bangalore

Job Description

As a Tech writer you should possess following skills Technical writing skills, GxP guidelines, SDLC Research skills, Proofreading, Ophthalmology As a Software Development Technical Writer will be responsible for creating, maintaining, and updating technical documentation throughout the different phases of the Software Development Life Cycle (SDLC) for our life sciences software products. This includes user manuals, API documentation, developer guides, and online help systems. The ideal candidate will have a deep understanding of both life sciences and software development principles, with the ability to translate complex technical concepts into clear, concise, and user-friendly documentation. You will collaborate closely with cross functional teams to develop comprehensive documentation that fosters operational efficiency and regulatory compliance. Your key responsibilities include: • Collaborate with stakeholders to understand the requirements and specifications of the QMS for NGP application. • Create documentation for various SDLC phases, including requirements, design specifications, development notes, testing procedures, and deployment guides • Create diagrams, charts, and other visual aids to enhance understanding of technical content. • Create templates and forms for recording and tracking quality metrics, including bug reports, test cases, and compliance documentation. • Ensure all documentation aligns with relevant regulatory standards such as HIPAA, GDPR, GCP, GDP, 21 CFR part 11, etc. • Ensure quality documentation has adhered to accuracy, completeness, and compliance with established standards. • Work closely with quality assurance team to incorporate feedback and updates on QMS documentation based on changes in NGP development. • Implement and maintain a robust document control system to manage versioning, access control and utilization of QMS documentation. Education • Postgraduate/Graduate in Life Science • Firm understanding of SDLC (systems development lifecycle) • Previous experience in technical writer or quality assurance specialist with a focus on medical device software or healthcare applications • Strong understanding of quality management principles including quality management standards (GCP, GDP, etc) Required Skills • 5+ years of experience in technical writing, preferably in the life sciences or software development industry. • Strong understanding of evolving regulatory guidelines (FDA, EMA, GDPR, 21 CFR Part 11, GXP, etc) • Understanding of compliance frameworks and how they apply to data management • Knowledge of quality assurance principles and practices • Proven experience as a business analyst in regulatory management • Ability to write user-friendly, engaging copy about highly technical subjects. • Ability to understand and accurately translate technical information for a general audience. • Familiarity with content and learning management systems (CMS and LMS). Preferred Skills: • Familiarity with Agile development methodologies. • Knowledge of content management systems (CMS) and version control systems (e.g., Git). • Strong written communication skills. • Ability to prioritize multiple simultaneous deadlines. • Technical writing experience. • Experience with product development, including past use of product development software. • Proven ability to quickly learn and understand complex subject matter • Experience in writing documentation and procedure manuals for various audiences