Job
Description
We are a technology-led healthcare solutions provider driven by the purpose to enable healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, you will gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. If you are looking to explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com. Jump-start your career with Indegene where we understand the importance of the first few years in shaping your professional journey. We promise you a differentiated career experience working at the exciting intersection of healthcare and technology. You will be mentored by some of the brightest minds in the industry, offering a global fast-track career opportunity to grow along with Indegene's high-speed growth. We are a purpose-driven organization that enables healthcare organizations to be future-ready, with customer obsession at the core of our operations. Our actions are bold, decision-making nimble, and work ethic industrious. **Must Have:** - **Education:** MBBS/PhD/MDS/BDS/MPharm/PharmD - **Experience:** 4 to 6 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) - **Role Purpose:** Lead Medical Writer is responsible for the development and review of medical writing deliverables supporting the clinical regulatory writing portfolio and training junior writers. **Skills Required:** - Authoring various clinical document types supporting regulatory filings - Excellence in focused writing and editing following defined processes - Leading cross-functional teams to draft scientific/medical content - Understanding the clinical development process from program planning to submission - Effective time management, organizational, and interpersonal skills - Customer focus and ability to work independently while following structured processes - Ability to move across Therapeutic Areas to support business continuity - Develop, coordinate, and oversee work plans for multiple-document delivery - Facilitate review meetings, address feedback, and negotiate solutions **Knowledge Requirement:** - Strong scientific knowledge and understanding of regulatory guidelines - Ability to interpret data and apply scientific knowledge to support regulatory document writing - Manage messaging for consistency and alignment with the agreed-upon strategy - Comfortable working on cross-functional teams and providing insights based on previous experiences - Experience writing protocols, amendments, CSR, and CTD summary documents **Good to Have:** - Expert authoring in MS Word and understanding MS Word functionality - Experience working in document management systems and managing workflows - Flexibility in adapting to new tools and technology - Capable of training writers/authors on the use of templates, guidelines, and tools **Responsibilities:** - Prepare/review clinical study reports, protocols, investigator brochures, and submission data summaries - Apply lean authoring principles and coordinate document review activities under aggressive timelines - Develop and maintain project plans and work as an active member of cross-functional teams - Ensure adherence to standard content, lean authoring, and messaging across team members - Conduct literature searches and screening as needed - Share lessons learned, best practices, and ensure compliance with company training **Equal Opportunity:** Indegene is an equal opportunity employer dedicated to providing a diverse and inclusive workplace for all employees.,
