Job Description

Date:

22 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 fast-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: Life Science Degree

EXPERIENCE: Minimum 3 years of writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)

ROLE PURPOSE: MW is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals

SKILLS:

Experienced in authoring multiple clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs); experience in writing some clinical summary documents (Module 2.5, 2.7) preferred 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 Communication skills commensurate with a professional working environment 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 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 timelines in project tracking application following standard templates 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

Understanding of International Council on Harmonization (ICH) guidelines and other regional guidelines such as those from the European Union and United States Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, clinical summaries) Understanding of medical practices regarding procedures, medications, and treatment for different disease states

Technology Skills

Expert authoring in MS Word, understanding of MS Word functionality Experience working in document management systems; managing workflows through tools Experience working with MS 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:

With minimal guidance from senior members of writing staff prepare clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development using existing systems and processes Utilize concept of lean authoring in the authoring process Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines Coordinate and facilitate document kick-off meetings with writers and cross-functional representatives Ensure adherence to standard content, lean authoring, and messaging across team members Ensure communication channels remain open and information is disseminated appropriately Work as an active member of cross-functional teams Conduct appropriate literature searches and literature screening, when required 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.