Job Title:
Senior Associate Manager - Regulatory Writing
Job Location:
Bangalore, Karnataka, India
Company:
Lilly
Job ID:
R-84213
Category:
Research & Development
Job Type:
Full-Time Regular
Role Overview:
The Senior Associate Manager in Regulatory Writing will work with cross-functional teams to lead the development of regulatory documents for clinical development and product registration. This includes creating, managing, and ensuring the quality and compliance of documents intended for regulatory bodies. The role involves content strategy, project management, and knowledge sharing across various therapeutic areas.
Primary Responsibilities:
Content Strategy and Execution:
Create and evaluate content strategy for writing projects.
Plan, write, edit, and finalize regulatory documents such as clinical study reports, regulatory responses, Investigational New Drug Applications (IND), and marketing authorization applications.
Conduct document initiation meetings to align with team members.
Coordinate scientific reviews and ensure quality checks for accuracy.
Project and Stakeholder Management:
Lead the writing process and apply project management skills to ensure timely delivery.
Build and communicate project timelines and mitigate risks.
Collaborate with stakeholders for smooth document development.
Knowledge and Skills Development:
Maintain and enhance knowledge of regulatory guidelines, therapeutic areas, and compound-specific information.
Participate in clinical planning and submission strategy planning.
Continuously improve scientific communication skills and adapt to new technologies.
Knowledge Sharing:
Coach and mentor junior staff and share technical expertise.
Contribute to process improvements and share best practices across the team.
Minimum Qualification Requirements:
Bachelor’s degree in a scientific, health, or related field.
Over 6 years of experience in Medical Writing.
Strong communication, interpersonal, and technical writing skills.
Demonstrated expertise in regulatory or clinical trial document writing.
Preferred Qualifications:
Graduate degree in life sciences or formal research component.
Expertise in specific therapeutic areas (e.g., oncology, neuroscience, immunology).
Experience with clinical development or regulatory activities.
Other Information:
High-level computer skills (e.g., word processing, spreadsheets, presentation tools).
Experience in project management and time management.
Equal Opportunity Employer:
Lilly is committed to diversity and inclusion, ensuring equal opportunities for all candidates regardless of race, gender, sexual orientation, or disability. If you need accommodation during the application process, please visit Lilly's Accommodation Request Form.
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