Company: Inductive Quotient Analytics

Location: Hyderabad

Experience: 4-7 years

Employment Type: Full-time

Job Title: Medical Writer/Senior Medical Writer

About Inductive Quotient Analytics
Inductive Quotient Analytics is an AI-powered Full-Service CRO, ClinTech, HealthTech, and Data Intelligence partner supporting pharma, biotech, medical device, and life sciences organizations. We provide clinical research services, functional service provider models, medical device support, regulatory and medical writing, clinical data management, biostatistics, statistical programming, pharmacovigilance, real-world evidence, and AI-enabled clinical trial technology solutions.

Job Summary

The Medical Writer is responsible for preparing, reviewing, and maintaining high-quality scientific, clinical, and regulatory documents related to drugs, clinical trials, bioavailability/bioequivalence (BA/BE) studies, and regulatory submissions. The role ensures that documents are scientifically accurate, compliant with applicable regulatory requirements, and aligned with sponsor and organizational standards.

Key Responsibilities

- Prepare, review, and maintain Clinical Trial Protocols, Protocol Amendments, Investigator Brochures (IBs), Informed Consent Documents (ICDs/ICFs), and Clinical Study Reports (CSRs) in compliance with applicable regulatory guidelines and industry standards.
- Develop, review, and support documentation related to Clinical Trial Agreements (CTAs) and associated study documents.
- Prepare, review scientific summaries, study reports, medical narratives, and other clinical research documentation to support study conduct and regulatory submissions.
- Prepare and review safety-related documents, including Safety Narratives, Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans, and adverse event/reliable adverse event documentation.
- Analyze, interpret, and summarize clinical and non-clinical data from diverse scientific and regulatory sources.
- Compile, author,



and format regulatory submission dossiers, including Common Technical Document (CTD) and electronic CTD (eCTD) modules.
- Draft regulatory correspondence, responses to health authority queries, clarification letters, compliance reports, and supporting documentation for regulatory inspections and submissions.
- Prepare and review scientific publications, manuscripts, abstracts, conference posters, presentations, and other medical communication materials.
- Collaborate effectively with cross-functional teams, including Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Sponsors, and Investigators to ensure timely and high-quality document delivery.
- Participate in project meetings, provide scientific writing expertise, and support study teams throughout the clinical development lifecycle.
- Ensure all documents are scientifically accurate, internally consistent, and compliant with applicable regulations, Good Clinical Practice (GCP), and organizational procedures.
- Maintain document version control, quality standards, and timely completion of assigned writing projects.

Educational Qualifications

- MBBS / PharmD / M.Pharm / M.Sc. (Life Sciences, Clinical Research, Biotechnology, Pharmacology, Biochemistry, Microbiology, or related discipline).

Required Skills

- Strong scientific and medical writing skills.
- Knowledge of clinical trial processes and regulatory requirements.
- Excellent literature review and data interpretation skills.
- Proficiency in Microsoft Word, Excel, PowerPoint, and document management systems.
- Robust attention to detail and quality.

Key Competencies

- Scientific accuracy
- Regulatory compliance awareness
- Analytical thinking
- Effective communication
- Time management
- Project management
- Team collaboration

Deliverables

- Clinical Trial Protocols
- Investigator Brochures
- Informed Consent Forms
- Clinical Study Reports
- Regulatory Submission Packages
- Safety Reports
- Publications and Scientific Manuscripts
- Regulatory Responses and Compliance Documentation

📌 Medical Writer (Hyderabad)
🏢 Inductive Quotient Analytics India
📍 Hyderabad