- Develop and review content for various regulatory documents; ensure quality as per set regulatory standards and compliance requirement.
- Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format.
- Authoring of protocols, CSRs, IBs, ICFs, Lay Summaries and other Module 2 documents

SKILLS:
- Positive communication skills (Written and Oral)
- MS Office (Excel and Power point)

PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES:
Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects)
- Responsible for developing 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 )
- Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development




- Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory 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 referencing
- Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones
- Work with internal stakeholders for project execution and actively participate in team meetings and client

📌 Senior Associate (Bengaluru)
🏢 Indegene
📍 Bengaluru