Eli Lilly Hiring Scientific Writer – Toxicology & Non-Clinical Submissions
- Eli Lilly Hiring Scientific Writer – Toxicology & Non-Clinical Submissions | Pharmacy, Life Sciences & Clinical Research Professionals Apply
- Company Overview
- Job Role & Responsibilities
- Scientific Writing & Regulatory Documentation
- Non-Clinical Submission Management
- Project & Stakeholder Management
- Scientific Data Interpretation
- Regulatory Compliance Activities
- Knowledge Sharing & Process Improvement
- Eligibility / Qualifications
- Educational Qualification
- Experience Required
- Required Skills
- Technical Skills
- Preferred Domain Knowledge
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- 1. What qualifications are required for the Scientific Writer position at Eli Lilly?
- 2. What type of documents will the selected candidate prepare?
- 3. Is regulatory writing experience required?
- 4. What therapeutic and scientific areas are involved in this role?
- 5. Is knowledge of eCTD submissions important?
- 6. Where is the job located?
- Job Summary
Eli Lilly Hiring Scientific Writer – Toxicology & Non-Clinical Submissions | Pharmacy, Life Sciences & Clinical Research Professionals Apply
Eli Lilly and Company is hiring Scientific Writers for its Global Scientific Communications team in Bengaluru. This opportunity is ideal for professionals with expertise in toxicology, non-clinical regulatory submissions, scientific writing, regulatory documentation, and drug development.
The selected candidate will work closely with multidisciplinary teams to prepare high-quality regulatory documents supporting global drug development programs. The role offers exposure to nonclinical study reports, regulatory submissions, eCTD documentation, Investigational New Drug (IND) applications, Marketing Authorization Applications (MAA), toxicology reports, and scientific communications intended for global regulatory authorities.
For candidates seeking careers in regulatory writing, non-clinical development, scientific communications, toxicology documentation, and pharmaceutical regulatory affairs, this is a valuable opportunity to work with one of the world’s leading healthcare companies.
Company Overview
Eli Lilly and Company is a global pharmaceutical organization headquartered in Indianapolis, Indiana, USA. The company focuses on discovering, developing, manufacturing, and delivering innovative medicines across multiple therapeutic areas.
Lilly has established itself as a leader in pharmaceutical research, biotechnology innovation, drug development, clinical research, and regulatory science. With a strong global presence, the company continues to invest in scientific innovation and patient-focused healthcare solutions.
Job Role & Responsibilities
Scientific Writing & Regulatory Documentation
- Plan, write, edit, review, and finalize non-clinical regulatory documents.
- Prepare ADME study reports supporting product development and registration.
- Develop toxicology and non-clinical study reports.
- Prepare briefing documents and regulatory responses.
- Support Investigational New Drug (IND) applications.
- Contribute to Marketing Authorization Applications (MAA).
- Ensure scientific accuracy, consistency, and regulatory compliance.
Non-Clinical Submission Management
- Lead preparation of non-clinical regulatory submission packages.
- Coordinate submission planning and execution activities.
- Manage document timelines and deliverables.
- Track document approvals and publishing activities.
- Support eCTD submission readiness.
Project & Stakeholder Management
- Collaborate with Toxicology, Pathology, Pharmacokinetics, Pharmacodynamics, and ADME teams.
- Work closely with discovery scientists and regulatory stakeholders.
- Conduct submission planning meetings.
- Communicate project timelines and progress updates.
- Identify and mitigate project risks.
Scientific Data Interpretation
- Analyze and summarize scientific and non-clinical data.
- Ensure clear presentation of study findings.
- Maintain consistency across regulatory documents.
- Support scientific conclusions with evidence-based interpretations.
Regulatory Compliance Activities
- Ensure compliance with global regulatory requirements.
- Follow scientific communication standards.
- Support regulatory submission quality checks.
- Maintain documentation according to industry guidelines.
Knowledge Sharing & Process Improvement
- Stay updated with evolving regulatory guidelines.
- Support training and mentoring activities.
- Share best practices across teams.
- Contribute to continuous process improvements and operational excellence.
Eligibility / Qualifications
Educational Qualification
Candidates with qualifications in Pharmacy, Life Sciences, Toxicology, Biotechnology, Clinical Research, Biomedical Sciences, and related scientific disciplines are encouraged to apply.
Eligible educational backgrounds include:
B.Pharm, M.Pharm, Pharm D, MSc Toxicology, MSc Pharmacology, MSc Biotechnology, MSc Microbiology, MSc Biochemistry, MSc Life Sciences, Clinical Research, Biomedical Sciences, Pharmaceutical Sciences, Regulatory Affairs, Drug Regulatory Affairs, Pharmacokinetics, Toxicology, Molecular Biology, Biotechnology, and related fields.
Experience Required
- Experience in Scientific Writing, Regulatory Writing, Medical Writing, or Non-Clinical Documentation.
- Experience supporting regulatory submissions is preferred.
- Experience in toxicology, ADME, pharmacokinetics, or drug development documentation will be advantageous.
Required Skills
- Scientific Writing
- Regulatory Writing
- Non-Clinical Documentation
- Toxicology Reporting
- Regulatory Submissions
- eCTD Documentation
- Clinical and Non-Clinical Data Interpretation
- Project Management
- Stakeholder Management
- Scientific Communication
- Regulatory Compliance
Technical Skills
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Electronic Document Management Systems
- Regulatory Submission Platforms
- eCTD Documentation Systems
- Scientific Publishing Tools
Preferred Domain Knowledge
Candidates with knowledge of the following areas will be preferred:
- Toxicology
- Non-Clinical Drug Development
- ADME Studies
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Pathology
- Environmental Risk Assessment
- Regulatory Affairs
- IND Submissions
- Marketing Authorization Applications
Location & Salary
Location: Bengaluru, Karnataka
Salary: ₹10 LPA – ₹20 LPA (Approximate Industry Standard Based on Experience and Expertise)
Application Process
Interested candidates can apply through the official Lilly Careers portal.
Frequently Asked Questions (FAQs)
1. What qualifications are required for the Scientific Writer position at Eli Lilly?
Candidates with B.Pharm, M.Pharm, Pharm D, MSc Toxicology, Pharmacology, Biotechnology, Clinical Research, Life Sciences, and related scientific qualifications are eligible.
2. What type of documents will the selected candidate prepare?
The role involves preparing ADME reports, toxicology reports, non-clinical study reports, regulatory responses, IND submissions, and Marketing Authorization Application documents.
3. Is regulatory writing experience required?
Experience in scientific writing, regulatory writing, medical writing, or non-clinical documentation is highly preferred.
4. What therapeutic and scientific areas are involved in this role?
The role supports Toxicology, ADME, Pharmacokinetics, Pharmacodynamics, Pathology, and Non-Clinical Drug Development programs.
5. Is knowledge of eCTD submissions important?
Yes. The selected candidate will support non-clinical eCTD content planning, preparation, and submission coordination.
6. Where is the job located?
The position is based in Bengaluru, Karnataka.
Job Summary
| Category | Details |
|---|---|
| Company | Eli Lilly and Company |
| Department Vacancies | Scientific Writer – Global Scientific Communications (Toxicology & Non-Clinical Submissions) |
| Qualification | B.Pharm, M.Pharm, Pharm D, MSc, Toxicology, Pharmacology, Biotechnology, Clinical Research and Related Disciplines |
| Experience | Scientific Writing / Regulatory Writing Experience Preferred |
| Location | Bengaluru, Karnataka |
To apply for this job please visit careers.lilly.com.
