- Full Time
- LCCI, Bangalore
Website Lilly
Job Title:
Senior Associate Manager – Regulatory Writing
About Lilly
At Lilly, we are committed to uniting care with discovery to enhance lives worldwide. As a global leader in healthcare, headquartered in Indianapolis, Indiana, we are dedicated to discovering and delivering life-changing medicines, improving disease management, and giving back to our communities through philanthropy and volunteer efforts. Our people-first approach drives us to give our best every day, making a positive impact across the globe. We are seeking motivated individuals who share our vision of making life better for people around the world.
Position: Senior Associate Manager – Regulatory Writing
Position Overview
As a Senior Associate Manager – Regulatory Writing, you will collaborate with cross-functional, multidisciplinary teams to create key documents for regulatory submissions. These documents include clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications (INDs), and marketing authorization applications. Your expertise in regulatory writing will be instrumental in ensuring the clarity and accuracy of these critical communications.
Key Responsibilities
- Lead the development of high-quality regulatory documents, ensuring they are scientifically sound and comply with regulatory requirements.
- Collaborate with internal teams, including clinical, scientific, and regulatory teams, to gather necessary information.
- Ensure timely delivery of well-organized and precise regulatory submissions.
- Participate in cross-functional discussions to understand project needs and objectives.
Candidate Profile
- Bachelor’s degree in a scientific, health-related, communications, or technology-related field.
- Proven experience in technical or regulatory scientific writing.
- Strong communication and interpersonal skills to work effectively with cross-functional teams.
- Completion of a writing exercise is required as part of the candidate evaluation process.
Additional Information
- Qualification: Bachelor’s degree required.
- Location: LCCI, Bangalore.
- Industry: Pharmaceuticals, Healthcare, Clinical Research.
- Functional Area: Research & Development.
- End Date: 30th October 2024.
Join us at Lilly, where your skills in regulatory writing will contribute to making life better for people around the world.
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