Regional Medical Affairs Specialist | Clinical Trials & Medical Affairs | Mumbai
Company: Abbott
Location: Mumbai, India
Job Type: Full-Time
Work Mode: On-site
Experience: 7+ Years
Job Overview
Abbott is hiring a Regional Medical Affairs Specialist to drive advanced clinical research, medical affairs strategy, and regulatory compliance across therapeutic areas. This role is designed for experienced professionals who can manage complex clinical trials (Phase III & IV), scientific strategy, and cross-functional collaboration.
As a senior individual contributor, you will play a critical role in clinical development, investigator engagement, and real-world data generation, ensuring high-quality execution aligned with global standards like ICH-GCP and pharmacovigilance frameworks.
Key Responsibilities
Clinical Trials & Research Leadership
Lead planning, execution, and oversight of clinical trials (Phase III & IV)
Drive implementation of clinical protocols and study strategies
Ensure timely completion of studies and final clinical reports
Investigator & Study Management
Recruit and manage clinical investigators and research sites
Negotiate study designs, budgets, and operational frameworks
Oversee investigator initiation meetings and multi-site studies
Regulatory & Compliance Oversight
Coordinate documentation and reporting for regulatory submissions
Ensure adherence to ICH-GCP, SOPs, and global compliance standards
Monitor protocol adherence and determine study completion
Pharmacovigilance & Safety Monitoring
Manage adverse event (AE) reporting and safety surveillance
Support pharmacovigilance systems and regulatory safety compliance
Data Management & Reporting
Oversee clinical data collection, validation, and reporting
Provide key inputs for submissions to regulatory authorities
Ensure data quality, accuracy, and audit readiness
Strategic Collaboration & Consulting
Act as liaison with internal teams and external partners
Support collaborations under licensing and co-development agreements
Contribute to medical strategy and scientific decision-making
Required Skills & Qualifications
Educational Qualification
Associate Degree or higher in Life Sciences / Pharmacy / Medical field
Experience
Minimum 7+ years experience in Medical Affairs / Clinical Research / Pharma Industry
Technical Skills
Strong expertise in clinical trials (Phase III & IV)
In-depth knowledge of ICH-GCP, regulatory requirements, and SOPs
Experience in pharmacovigilance (PV) and adverse event reporting
Familiarity with clinical data management and regulatory submissions
Core Competencies
Advanced problem-solving and analytical skills
Strong stakeholder and investigator management
Ability to manage complex, multi-site clinical projects
Excellent communication and leadership influence
High attention to detail and compliance orientation
Perks & Benefits
Opportunity to work with a leading global pharmaceutical company
Exposure to complex global clinical trials and medical strategies
Career growth in Medical Affairs leadership and clinical development
Work on innovative therapies across therapeutic areas
Cross-functional exposure with global teams and stakeholders
Compensation
Salary Range: Not disclosed (competitive as per industry standards for senior roles)
About the Company
Abbott is a global healthcare leader focused on pharmaceutical innovation, diagnostics, medical devices, and nutrition science. With a strong commitment to clinical research and patient-centric solutions, Abbott continues to advance healthcare outcomes worldwide.
Why This Role is High-Impact
This role is ideal for professionals aiming to excel in:
Medical Affairs & Clinical Strategy
Clinical Trials & Drug Development Lifecycle
Pharmacovigilance & Drug Safety
Regulatory Affairs & Global Compliance
Healthcare Innovation & Scientific Leadership
Application Process
Apply through Abbott’s official careers portal.
Call to Action
If you want to operate at a senior level in clinical research and medical affairs, managing complex trials and influencing real-world healthcare outcomes — this is your arena.
Step into high-impact pharma strategy, advanced clinical execution, and global exposure.
Apply now and elevate your career in the pharmaceutical industry. 🚀
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