Job Title: NT – Senior Associate – Scientific Writing
Date Posted: 11 Sept 2025
Location: Bangalore, Karnataka, India
About the Company
Indegene is a technology-led healthcare solutions provider with a mission to enable healthcare organizations to be future-ready. We provide global growth opportunities for bold, industrious, and nimble talent.
At Indegene, you will:
Work at the unique intersection of healthcare and technology.
Be mentored by industry leaders.
Build a strong career foundation through global, fast-track opportunities.
Thrive in a culture built on innovation, collaboration, empathy, and customer obsession.
Explore more at: www.careers.indegene.com
Role Purpose
The Lead Medical Writer (Senior Associate – Scientific Writing) is responsible for developing and reviewing medical writing deliverables that support the clinical regulatory writing portfolio and for training junior writers.
Education & Experience
Education: MBBS / PhD / MDS / BDS / MPharm / PharmD
Experience: 4–6 years in clinical and regulatory writing supporting global filings (CTD Modules 2 and 5).
Key Responsibilities
Author and review clinical/regulatory documents: study reports, protocols, amendments, investigator brochures, and CTD summaries.
Apply lean authoring principles and structured content management tools/text libraries.
Lead document development from planning to submission while ensuring adherence to templates, processes, and timelines.
Coordinate document review meetings, consensus discussions, quality control, and finalization.
Drive cross-functional collaboration to ensure aligned and consistent messaging.
Provide oversight and guidance to junior writers.
Conduct literature searches and stay updated on evolving regulatory requirements.
Participate in departmental initiatives, knowledge sharing, and best practices.
Ensure compliance with company training, processes, and reporting standards.
Skills & Competencies
Core Skills:
Experience authoring diverse clinical document types (Module 2.4–2.7, Module 5.2, CSRs, IBs, protocols).
Strong writing/editing skills with attention to clarity, accuracy, and compliance.
Ability to lead cross-functional teams and manage document-related deliverables.
Effective time management, organization, and interpersonal communication.
Strong customer focus and ability to work independently.
Flexibility to support across therapeutic areas.
Scientific Knowledge:
Strong knowledge of global regulatory guidelines (EU, US, and regional).
Ability to interpret clinical data and build scientific/regulatory arguments.
Understanding of medical practices, treatments, and disease states.
Skill in managing consistency of messaging across documents.
Proven ability to apply therapeutic knowledge and provide scientific insights.
Technology Skills (Good to Have):
Expert proficiency in MS Word and formatting tools.
Experience with document management systems and e-approval workflows.
Familiarity with Word add-ins for managing styles, references, and templates.
Ability to train other writers in templates, guidelines, and tools.
Good to Have
Flexibility in adapting to new tools and technologies.
Ability to oversee multiple-document delivery with defined tasks, timelines, and responsibilities.
Skills in facilitating review meetings, negotiating solutions, and addressing feedback.
Equal Opportunity Statement
Indegene is an Equal Employment Employer committed to fostering inclusion and diversity.
We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. Employment decisions are based on merit, qualifications, and business needs.
All qualified applicants will receive consideration without regard to race, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristic.
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