Senior Scientific Writer
Company: Abbott
Location: Mumbai, Maharashtra, India (Mumbai Development Center – EPD)
Job Category: Medical and Clinical Affairs
Job Type: Full-Time
Experience Required: Minimum 5+ years of experience in medical writing or clinical regulatory documentation within the pharmaceutical, biotechnology, or clinical research industry
Education: Advanced degree such as Master’s, PhD, PharmD, MD, or equivalent in Life Sciences, Pharmacy, Medicine, or related scientific discipline
Job Overview
Abbott is seeking a Senior Scientific Writer to join its Clinical Science team at the Mumbai Development Center. This role focuses on developing high-quality clinical regulatory documents, particularly Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summary), for global regulatory submissions.
The Senior Scientific Writer will work closely with Clinical Directors and cross-functional teams to develop scientifically accurate, compliant, and submission-ready clinical documentation that supports regulatory approvals across multiple therapeutic areas.
Key Responsibilities
Clinical Regulatory Document Authoring
Independently author, revise, and finalize Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summary) documents for global regulatory submissions.
Ensure clinical documentation aligns with company standards, ICH guidelines, and global regulatory requirements.
Maintain scientific accuracy and consistency across all clinical documents supporting regulatory submissions.
Cross-Functional Scientific Collaboration
Collaborate with Clinical Directors and Clinical Science teams across multiple therapeutic areas to gather scientific inputs and verify interpretations.
Integrate feedback from cross-functional stakeholders into cohesive, submission-ready clinical documentation.
Ensure the scientific narrative accurately reflects clinical development strategies and therapeutic positioning.
Clinical Documentation Planning and Strategy
Review clinical development timelines and proactively plan medical writing activities to meet key regulatory submission milestones.
Provide guidance on documentation requirements and identify opportunities to improve writing processes and efficiency.
Regulatory Submission Support
Prepare and coordinate the completion of clinical components of regulatory submission dossiers.
Ensure consistency across clinical documentation, particularly following database updates or changes in clinical strategy.
Support Clinical Directors in preparing responses to regulatory authority queries related to clinical modules.
Compliance and Regulatory Standards
Maintain current knowledge of clinical documentation requirements from major global health authorities.
Monitor updates in regulatory guidelines and communicate potential impacts to management and leadership teams.
Serve as a subject matter expert in clinical documentation processes, tools, and regulatory submission requirements.
Strategic Planning with Global Labeling Teams
Collaborate with Global Labeling teams to develop annual plans for clinical documentation supporting product lifecycle activities.
Support product renewals, safety updates, and regulatory maintenance through updates to Modules 2.5 and 2.7.
Align clinical documentation strategies with labeling objectives and regulatory commitments.
Clinical Study Documentation Support
Prepare or coordinate time-sensitive clinical reports and regulatory documents related to the planning, conduct, and reporting of clinical studies.
Ensure the scientific narrative reflects the clinical perspectives defined by Clinical Directors and departmental leadership.
Stakeholder Coordination
Collaborate with external partners including CROs, development partners, and regional affiliates.
Coordinate with internal teams such as data management, biostatistics, and regulatory publishing to ensure the accuracy of tables, figures, and appendices.
Required Skills and Competencies
Extensive experience in clinical regulatory writing and medical documentation development.
Strong expertise in developing clinical overview and clinical summary documents (Module 2.5 and 2.7).
Solid understanding of clinical development processes, clinical trial operations, and regulatory frameworks.
High proficiency in Microsoft Word and electronic document management systems.
Strong organizational skills with the ability to manage multiple writing projects simultaneously.
Excellent written and verbal communication skills in English.
Preferred Qualifications
Experience working with Global Labeling or Regulatory Affairs teams.
Familiarity with therapeutic areas relevant to the company’s product portfolio.
Experience collaborating with cross-functional global clinical development teams.
Professional Skills
Strong attention to detail and scientific accuracy.
Ability to manage complex documentation projects within tight regulatory timelines.
Excellent collaboration and stakeholder management skills.
Ability to translate complex clinical data into clear, structured scientific narratives.
Equal Opportunity Employer
Abbott is committed to creating an inclusive workplace and providing equal employment opportunities to all qualified individuals regardless of race, gender, religion, age, disability, sexual orientation, or other protected characteristics.
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