Senior Scientific Writer | Clinical Regulatory Writing | Mumbai
Company: Abbott
Location: Mumbai, India (Mumbai Development Center – EPD)
Job Type: Full-Time
Work Mode: On-site
Experience: 5+ Years (Medical Writing & Clinical Submissions)
Job Overview
Abbott is hiring a Senior Scientific Writer to lead high-impact clinical regulatory writing for global submissions. This role is central to authoring CTD Modules 2.5 (Clinical Overview) and 2.7 (Clinical Summary), ensuring scientific accuracy, regulatory compliance, and alignment with clinical strategy.
As part of the Clinical Science Team, you will collaborate with Clinical Directors and cross-functional stakeholders to deliver submission-ready clinical documents, supporting drug approvals, lifecycle management, and global regulatory strategy.
This is a premium opportunity for professionals aiming to grow in medical writing, regulatory affairs, and clinical development.
Key Responsibilities
Clinical Regulatory Writing
Independently author and finalize CTD Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summary)
Ensure alignment with ICH guidelines, regulatory expectations, and company standards
Maintain consistency across all clinical documents for global submissions
Cross-Functional Collaboration
Work closely with Clinical Directors and Clinical Science teams
Integrate feedback from cross-functional stakeholders into cohesive documents
Collaborate with biostatistics, data management, publishing, and regulatory teams
Regulatory Submission Support
Prepare clinical components of registration dossiers
Support responses to Health Authority queries (FDA, EMA, global agencies)
Ensure document updates post database lock and strategy changes
Planning & Documentation Strategy
Plan medical writing deliverables aligned with clinical development timelines
Identify process improvements and documentation efficiencies
Provide guidance on clinical documentation requirements
Compliance & Quality Assurance
Ensure adherence to ICH-GCP, CTD guidelines, and regulatory frameworks
Stay updated with evolving global regulatory requirements and EM markets
Act as SME for clinical documentation tools and processes
Global Labeling & Lifecycle Strategy
Collaborate with Global Labeling teams for annual documentation planning
Support product renewals, safety updates, and lifecycle management
Align documentation with labeling strategies and regulatory commitments
Additional Responsibilities
Support preparation of clinical study reports and regulatory documents
Liaise with CROs, affiliates, and co-development partners
Ensure accuracy of tables, figures, and appendices
Required Skills & Qualifications
Educational Qualification
Advanced degree: MSc / PhD / PharmD / MD / Life Sciences
Experience
5+ years in medical writing / clinical regulatory writing
Minimum 3+ years in CTD module authoring (2.5 & 2.7)
Technical Skills
Strong expertise in clinical regulatory writing and CTD documentation
In-depth knowledge of ICH-GCP, regulatory guidelines, and submission processes
Experience with clinical development, biostatistics, and study design
Familiarity with electronic document management systems (EDMS)
Proficiency in Microsoft Word and structured document authoring
Core Competencies
Exceptional scientific writing and storytelling ability
Strong analytical thinking and attention to detail
Ability to manage multiple high-priority deliverables
Excellent communication and stakeholder management skills
Strategic mindset with regulatory awareness
Perks & Benefits
Work with a global pharmaceutical leader in clinical innovation
Exposure to high-impact global regulatory submissions
Career growth in medical writing, HEOR, and regulatory strategy
Opportunity to work across multiple therapeutic areas
Collaborative environment with global clinical and regulatory teams
Compensation
Salary Range: Not disclosed (highly competitive for senior medical writing roles)
About the Company
Abbott is a leading global healthcare organization focused on pharmaceutical innovation, diagnostics, and medical technologies. With strong expertise in clinical development and regulatory science, Abbott continues to deliver impactful healthcare solutions worldwide.
Why This Role is High-Impact
This role is ideal for professionals aiming to master:
Medical Writing & Clinical Regulatory Documentation
CTD Modules (2.5 & 2.7) Authoring
Global Regulatory Submissions (FDA, EMA, Emerging Markets)
Clinical Development & Drug Approval Strategy
Lifecycle Management & Labeling Strategy
Application Process
Apply via Abbott’s official careers portal.
Call to Action
If you want to operate at the top tier of medical writing—authoring core regulatory documents that decide drug approvals—this is your opportunity.
Step into high-impact scientific writing, global submissions, and strategic clinical development.
Apply now and become a key player in bringing medicines to market. 🚀
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