Indegene

Identify serious adverse events and special scenarios. Indegene help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way.

This role involves researching, writing, and adapting scientific information into accurate, compliant, and engaging materials for healthcare professionals, patients, and other stakeholders.

Lead Medical Writer is responsible for the development and review of medical writing deliverables that support the clinical regulatory writing portfolio and train the junior writers.

Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams

The ideal candidate will serve as the single point of contact between the client and the vendor team, leading prioritization, innovation, and governance of medical information content in a complex, fast-paced environment.

Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science. Understanding of medical practices regarding procedures, medications, and treatment for different disease states.

To create complex and specialized content without supervision; manage end-to-end publication/medical education content development process including documentation.

Thorough knowledge of EU, MENA and ASEAN markets country requirements, regulatory affairs procedures for initial submission, licensing, post-approval submission management 

Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment