Full-Time Staff Engineer - Medical Writing

REQUIREMENTS:Total experience 7+ years.Strong working experience in Life-sciences, Healthcare and Medical WriterExperienced medical writer with expertise in CSR (clinical study report), Informed Consent forms (ICF), CMS- clinical module summaries, IB.Strong understanding of clinical trial processes, regulatory guidelines (ICH-GCP, FDA, EMA), and medical terminology.Experience in reviewing and validating machine-generated documents is a plus.Excellent written and verbal communication skills with the ability to provide detailed feedback.Ability to work independently and collaboratively in a cross-functional environment.Strong analytical and problem-solving skills.Strong communication skills are essential.

RESPONSIBILITIES:Understanding functional requirements thoroughly and analysing the client’s needs in the context of the projectEnvisioning the overall solution for defined functional and non-functional requirements, and being able to define technologies, patterns, and frameworks to realize it.Determining and implementing design methodologies and tool setsEnabling application development by coordinating requirements, schedules, and activities.Being able to lead/support UAT and production roll outs.Creating, understanding, and validating WBS and estimated effort for given module/task, and being able to justify it.Addressing issues promptly, responding positively to setbacks and challenges with a mindset of continuous improvementGiving constructive feedback to the team members and setting clear expectations.Helping the team in troubleshooting and resolving of complex bugsComing up with solutions to any issue that is raised during code/design review and being able to justify the decision taken.Carrying out POCs to make sure that suggested design/technologies meet the requirements.Bachelor’s or master’s degree in computer science, Information Technology, or a related field.

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