Global pharmaceutical leader Eli Lilly and Company (Lilly) has announced a new opportunity for professionals interested in Scientific Writing, Regulatory Submissions, Toxicology Documentation, and Non-Clinical Communications. The company is currently hiring a Scientific Writer – Global Scientific Communications Toxicology Non-Clinical Submissions for its Bengaluru office.

This position offers an excellent opportunity for life sciences professionals with expertise in regulatory writing, toxicology study reports, non-clinical submissions, ADME documentation, pharmacokinetics, pharmacodynamics, and eCTD submissions to contribute to global drug development programs.

Job Overview

About Lilly

Lilly is a global healthcare company headquartered in Indianapolis, Indiana, USA. The organization focuses on discovering and delivering innovative medicines that improve patient outcomes worldwide. Lilly operates across multiple therapeutic areas and maintains a strong commitment to scientific excellence, innovation, and patient care.

Key Responsibilities

The selected candidate will be responsible for preparing, managing, and coordinating scientific and regulatory documents supporting non-clinical drug development programs.

Scientific Writing & Document Development

• Plan, organize, write, review, and finalize non-clinical scientific documents.
• Prepare ADME study reports supporting regulatory submissions.
• Ensure scientific accuracy, clarity, consistency, and compliance.
• Develop outlines and author documents using standardized templates.
• Maintain consistency across multiple regulatory documents.

Regulatory Submission Support

• Support Investigational New Drug (IND) applications.
• Assist in Marketing Authorization Applications (MAA).
• Prepare briefing documents and regulatory responses.
• Coordinate non-clinical submission deliverables.
• Manage electronic Common Technical Document (eCTD) content.

Project Management

• Lead document timelines and submission planning.
• Coordinate reviews involving scientists and stakeholders.
• Monitor project milestones and deliverables.
• Identify risks and implement mitigation strategies.
• Communicate project status effectively.

Cross-Functional Collaboration

Work closely with:

• Toxicology Scientists
• ADME Scientists
• Pathologists
• Pharmacokinetic (PK) Experts
• Pharmacodynamic (PD) Scientists
• Discovery Biologists
• Environmental Risk Assessment Teams
• Regulatory Affairs Professionals

Knowledge Management

• Stay updated with global regulatory guidelines.
• Share best practices across teams.
• Support process improvement initiatives.
• Provide expertise on non-clinical submissions and document development.

Preferred Qualifications

Candidates with the following qualifications may be highly suitable:

Educational Background

• M.Pharm
• Pharm.D
• M.Sc Life Sciences
• Biotechnology
• Toxicology
• Pharmacology
• Biomedical Sciences
• Related Scientific Disciplines

Technical Skills

• Scientific Writing
• Regulatory Writing
• Toxicology Documentation
• Non-Clinical Study Reports
• IND Submissions
• eCTD Submissions
• ADME Documentation
• Pharmacokinetics (PK)
• Pharmacodynamics (PD)
• Project Management
• Document Publishing

Desired Experience

• Experience in pharmaceutical, biotechnology, CRO, or regulatory environments.
• Knowledge of global health authority submission requirements.
• Familiarity with non-clinical development processes.
• Strong communication and stakeholder management skills.

Why Join Lilly?

Lilly offers employees the opportunity to work on innovative medicines that impact millions of patients globally.

Benefits

• Global career growth opportunities
• Exposure to regulatory submissions worldwide
• Collaborative scientific environment
• Competitive compensation package
• Learning and development programs
• Inclusive and diverse workplace culture
• Opportunity to work with global drug development teams

How to Apply

Application Link