Date 5 Aug 2025 Location Bangalore KA IN We are a technology-led healthcare solutions provider We are driven by our purpose to enable healthcare organizations to be future-ready We offer accelerated global growth opportunities for talent that s bold industrious and nimble With Indegene you gain a unique career experience that celebrates entrepreneurship and is guided by passion innovation collaboration and empathy To explore exciting opportunities at the convergence of healthcare and technology check out www careers indegene com Looking to jump-start your career We understand how important the first few years of your career are which create the foundation of your entire professional journey At Indegene we promise you a differentiated career experience You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry We are offering a global quick-track career where you can grow along with Indegene s high-speed growth We are purpose-driven We enable healthcare organizations to be future ready and our customer obsession is our driving force We ensure that our customers achieve what they truly want We are bold in our actions nimble in our decision-making and industrious in the way we work Must Have EDUCATION MBBS PhD MDS BDS MPharm PharmD EXPERIENCE 5 to 10 years experience in writing Clinical Regulatory documents for global filings CTD Module 2 4 and Module 5 ROLE PURPOSE 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 SKILLS Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2 4 2 5 2 7 5 2 clinical study reports CSRs protocols amendments and Investigator Brochures IBs Demonstrated excellence in focused lean writing and editing following defined processes and templates Lead cross-functional teams to draft agreed-upon scientific medical content that addresses data interpretation product claims and internal external questions Understanding of clinical development process from program panning to submission including clinical trial design Communication skills commensurate with a professional working setting Effective time management organizational and interpersonal skills Customer focus Comfortable following directions templates and structured processes for delivering documents for review and finalization Able to work independently while maintaining communication with the Sponsor s MW project manager Ability to move across Therapeutic Areas to support business continuity and resource needs Ability to develop coordinate and oversee work plans for both individual and multiple-document delivery with all the needed tasks and subtasks timelines and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines Develop work plan and ensure adherence Ability to manage the tasks roles responsibilities and timing of the authoring team internal external contributors and reviewers to facilitate document completion Adherence to processes and Sponsor-defined best practices Ability to facilitate review meetings address feedback and negotiate solutions agreements KNOWLEDGE REQUIREMENT Scientific Knowledge Strong knowledge of regulatory guidelines requirements and other regional guidelines such as those from the European Union and the United States Ability to interpret data and apply scientific knowledge to support regulatory document writing ie IB protocols amendments CSR Clinical summaries 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 Manage messaging for consistency with historical information and in alignment with agreed-upon strategy Capable of providing insight alternatives and suggestions based on previous experiences Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring Experience writing protocols amendments CSR and CTD summary documents Technology Skills Expert authoring in MS Word understanding of MS Word functionality Experience working in document management systems managing workflows eApproval signatures Experience working with Word add-ins that facilitate the management of fonts styles references etc Flexibility in adapting to new tools and technology Capable of training writers authors on the use of templates guidelines and tools Good to have RESPONSIBILITIES Without guidance from senior members of the writing staff prepare review clinical study reports protocols investigator brochures submission data summaries and other regulatory documents on investigational drugs in various stages of clinical development Apply lean authoring principles as part of document development and when applicable structured content management text libraries as part of authoring process Coordinate and initiate activities for document review consensus meeting quality control and document finalization under aggressive timelines Develop and maintain project plans Work as an active member of cross-functional teams representing Medical Writing Coordinate and deliver document kick-off meetings with writers and cross-functional representatives Ensure adherence to standard content lean authoring and messaging across team members Ensure communication between members remain open and information is disseminated appropriately Possible participation in the orientation and coaching of junior team members Conduct appropriate literature searches and screening as needed Participate on Medical Writing department initiatives as appropriate Research regulatory requirements to remain current in the regulatory landscape Share lessons learned and best practices Ensure compliance with company training and time reporting EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity We do not discriminate on the basis of race religion sex colour age national origin pregnancy sexual orientation physical ability or any other characteristics All employment decisions from hiring to separation will be based on business requirements the candidate s merit and qualification We are an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race colour religion sex national origin gender identity sexual orientation disability status protected veteran status or any other characteristics