Associate - Regulatory Solutions Job in Bangalore at Indegene Limited

Indegene Limited is hiring for the role of Associate - Regulatory Solutions!

Responsibilities of the Candidate:

• Develop Content to Meet High CSAT Independently (Simple and Complex Projects)
• Develop new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD)
• Run and review literature searches in various databases and screening articles to obtain required information for content development
• Conduct quality checks to ensure the accuracy and consistency of data included in documents
• Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas
• Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism
• Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencin
• Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer one
• Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective
• Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security, and data privacy
• Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines
• Support in developing technical training programs for other team members relevant to the job
• Build expertise in assigned deliverables through self-learning and formal training and stay abreast with current trends in the respective areas

Requirements:

• Good communication skills (Written and Oral)
• MS Office (Excel and PowerPoint)