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Nt -Senior Associate - Scientific Writing

0-2 years
Not Disclosed
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