Job Title: Associate / Senior Associate / Lead - Regulatory Writing
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-87544
Company Overview:
Eli Lilly and Company (Lilly) is a global healthcare leader committed to improving lives through innovation, research, and compassionate care. Headquartered in Indianapolis, Indiana, Lilly aims to discover and deliver life-changing medicines.
Role Purpose:
The Scientific Communications Associate - Regulatory will contribute to the creation of accurate, objective, and balanced documents for regulatory audiences, supporting clinical development and product registration. This role involves collaboration with cross-functional teams and focuses on producing high-quality scientific regulatory documents.
Primary Responsibilities
1. Content Strategy and Execution
Author, edit, and finalize clinical regulatory documents (e.g., protocols, amendments, informed consent forms).
Lead initiation meetings and integrate feedback from cross-functional teams.
Ensure consistency and scientific rationale across all content.
Manage document quality checks and version control.
May collaborate with external vendors or alliance partners.
2. Project and Stakeholder Management
Use project management skills to meet writing deadlines.
Mitigate project risks and escalate as needed.
Communicate timelines and project status to stakeholders.
3. Knowledge and Skills Development
Maintain expertise in assigned therapeutic areas.
Stay updated on regulatory and scientific communication standards.
Support strategic planning efforts (e.g., clinical or submission strategies).
4. Knowledge Sharing
Coach and support team members by sharing expertise.
Contribute to process improvement and tool usage.
Promote best practices across teams and regions.
Qualifications
Bachelor’s degree in a scientific, healthcare, communications, or technology-related field.
Demonstrated experience in technical or regulatory scientific writing.
Strong communication and interpersonal skills.
Successful completion of a writing exercise (mandatory for evaluation).
Inclusivity Statement
Lilly is an equal opportunity employer committed to diversity, inclusion, and providing accommodations to applicants with disabilities.
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