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1700_Regulatory Writing Design Hub
English
₹15000/MONTH
1 Year
Bachelor's degree
Work From Office
Date Posted
07-Jul-2026
Location
Karnataka (KA), 1
Job Type
Full Time
Company
Group
Description
Job Details
- Job Type: Full-time
- Location: Bengaluru, Karnataka
Full Job Description
This job description provides an overview of the role’s requirements. Responsibilities may evolve over time, and additional tasks may be assigned as needed.
1. Content Strategy and Execution
Document Preparation, Development, and Finalization
- Gather and evaluate data, information, and inputs from various sources to create a cohesive content strategy.
- Plan, write, edit, review, and coordinate regulatory documents supporting clinical development and product registration.
- Conduct document initiation meetings to align the authoring team.
- Develop a scientific rationale for complex or strategic documents.
- Present data in a clear, complete, and concise manner.
- Ensure consistency in key data, statements, and conclusions across documents.
- Organize expert/scientific reviews and incorporate feedback to refine content.
- Perform quality checks for accuracy.
- Manage multiple document types efficiently.
- Work with internal and external experts to develop and prepare presentations.
- Build and maintain relationships with vendors and alliance partners as needed.
2. Project and Stakeholder Management
- Lead the writing process, applying project management skills to ensure timely delivery of regulatory documents.
- Develop and communicate writing project timelines.
- Anticipate and mitigate risks to project delivery.
- Collaborate with teams and stakeholders to facilitate smooth document development.
- Provide regular project status updates to stakeholders.
3. Knowledge and Skills Development
- Enhance expertise in assigned therapeutic areas, including disease states and compounds.
- Adapt to different document types, therapeutic areas, and compounds.
- Stay updated on regulatory and publication guidelines.
- Maintain an overarching view of compounds, therapeutic areas, and the external landscape (including competitors).
- Contribute to clinical planning, submission strategy, regulatory responses, and literature reviews.
- Improve scientific communication skills to align with audience needs and evolving technologies.
4. Knowledge Sharing
- Mentor and guide others by sharing technical expertise.
- Be recognized for proficiency in document development.
- Network with teams across functions and regions to share best practices.
- Recommend process improvements where applicable.
- Provide expertise in databases and document management systems.
Minimum Qualification Requirements
- Bachelor's degree in a scientific, health, communications, or technology-related field.
- Experience in technical or regulatory scientific writing.
- Strong communication and interpersonal skills.
- Successful completion of a writing exercise (part of the evaluation process).
Additional Preferred Qualifications
- Graduate degree with a formal research component in life sciences.
- Mastery of written and verbal English for medical, scientific, or technical writing.
- Knowledge and experience in clinical pharmacology, neuroscience, oncology, cardiovascular, immunology, or endocrine research.
- Experience in writing regulatory, clinical trial documents, or publications.
- Understanding of clinical development, clinical trials, or regulatory activities.
- Strong project and time management skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems.
This version is structured for clarity, making it easier for candidates to understand the job role. Let me know if you’d like any further refinements! ????
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