Indegene Inc. is hiring : Senior Associate - Scientific Writing in Indiana

Title : NT -Senior Associate - Scientific Writing

Date : 14 Oct 2025

Location : 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. Those looking to jump‑start their career can understand that the first few years of your career are foundational to your professional journey. At Indegene, we promise a differentiated career experience where you will work at the exciting intersection of healthcare and technology, mentored by some of the most brilliant minds in the industry. We offer a global fast‑track career where you can grow alongside Indegene’s high‑speed growth.

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 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, 2.6, 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 planning to submission, including clinical trial design

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 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 tasks, subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively

Develop work plan and ensure adherence

Ability to manage 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 (e.g., 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

Good to have

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 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

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.

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