Nt -Senior Associate - Scientific Writing

0-2 years

Not Disclosed

Bangalore

10 Sept. 16, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: NT - Senior Associate - Scientific Writing

Date Posted: 11 Sept 2025
Location: Bangalore, KA, India

Company Overview:

Indegene is a technology-led healthcare solutions provider enabling healthcare organizations to be future-ready. The company offers accelerated global growth opportunities for talent that is bold, industrious, and nimble. Employees gain a unique career experience guided by passion, innovation, collaboration, and empathy.

Key highlights:

Exposure to clinical and regulatory document writing supporting global filings
Mentorship from industry experts
Fast-track global career growth opportunities

Education & Experience Requirements:

Education: MBBS, PhD, MDS, BDS, MPharm, PharmD
Experience: 4–6 years in medical/scientific writing supporting clinical and regulatory documents (CTD Module 2 & Module 5)

Role Purpose:

The Senior Associate – Medical Writer is responsible for the development and review of medical writing deliverables supporting the clinical regulatory writing portfolio and mentoring junior writers.

Key Responsibilities:

Document Authoring & Review:

Independently prepare and review clinical study reports (CSRs), protocols, amendments, investigator brochures (IBs), and CTD summary documents.
Apply lean authoring principles and structured content management text libraries where applicable.
Ensure standardization of content, messaging, and regulatory compliance across all documents.

Project Management & Coordination:

Develop work plans for single or multiple documents, managing timelines, roles, and responsibilities.
Coordinate review, quality control, and finalization of documents under aggressive timelines.
Conduct document kick-off and review meetings with cross-functional teams.
Maintain open communication among team members and ensure timely dissemination of information.

Team Leadership & Training:

Mentor junior writers and participate in their orientation and coaching.
Train team members on templates, guidelines, tools, and best practices.
Share lessons learned and contribute to continuous improvement initiatives.

Regulatory & Scientific Expertise:

Interpret clinical and regulatory data to support document development.
Build clinical or regulatory arguments based on available data, logic, and therapeutic area knowledge.
Remain current with global and regional regulatory guidelines (EU, US, etc.)
Conduct literature searches and screening as needed.

Skills & Competencies:

Technical & Scientific Skills:

Expertise in clinical and regulatory writing for Module 2.4–2.7, 5.2, protocols, amendments, CSRs, IBs.
Strong knowledge of clinical development, trial design, and regulatory requirements.
Ability to work across multiple therapeutic areas.

Communication & Collaboration:

Strong written and verbal communication skills.
Ability to coordinate and lead cross-functional teams.
Customer-focused with professional communication skills.

Organizational & Time Management:

Effective time management, organizational, and interpersonal skills.
Ability to work independently while maintaining communication with project managers.

Technology Skills (Good to Have):

Expert in MS Word and its functionalities.
Experience with document management systems and workflow management (eApproval/signatures).
Familiarity with Word add-ins for managing fonts, styles, references.
Adaptability to new tools and technology.

Knowledge Requirements:

Regulatory guidelines and regional standards (EU, US).
Clinical, scientific, and medical knowledge relevant to document writing.
Ability to interpret data and provide insights for regulatory submissions.
Maintain consistency with historical information and messaging strategy.

Equal Opportunity:

Indegene is committed to inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications.

All qualified applicants will receive consideration without regard to:

Race, color, religion, sex, national origin
Gender identity or sexual orientation
Disability status or protected veteran status

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Nt -Senior Associate - Scientific Writing

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