Job Title:
Team Lead – Medical Writing (Drug Safety & Regulatory Affairs)
Location:
Gurgaon (On-site)
Employment Type:
Full-Time
Experience Required:
5+ Years
Posted:
2 days ago
Job Purpose:
To plan and manage Medical Writing activities for Regulatory and Pharmacovigilance verticals in compliance with applicable regulatory guidelines and standards.
Roles & Responsibilities:
Medical Writing & Documentation
Prepare high-quality medical and scientific documents from literature search to final delivery for internal and external clients.
Author regulatory and safety documents including:
CTD Modules
Medical Data Packages
SmPCs, PIs, PILs
Safety Reports & Aggregate Reports (PSUR/PBRER/PADER)
Risk Management Plans (RMPs) / Risk Evaluation & Mitigation Strategies (REMS)
Regulatory & Safety Operations
Manage and review aggregate reports — collecting, analyzing, authoring, and developing reports.
Perform scientific reviews of aggregate reports produced by PV Associates.
Support medical safety team in ongoing review and management of safety information.
Maintain and update Aggregate Report Tracker and perform periodic case reconciliation.
Conduct detailed searches on regulatory websites (US FDA, EMA, PMDA, TGA, UKMHRA) for safety alerts.
Project Management & Quality Assurance
Ensure document outputs and processes comply with client specifications, templates, and style guidelines.
Deliver projects within agreed timelines while maintaining high-quality standards.
Attend project initiation meetings and collate project briefs.
Contribute to operational excellence through clear communication and efficient coordination.
Leadership & Training
Mentor and guide associates on job skills and writing techniques.
Develop training materials and conduct training sessions for new hires and existing staff.
Support knowledge sharing and professional growth within the team.
Education & Experience:
Master’s degree in Pharmacology, Pharmacy, or Medicine (Advanced degree preferred).
Minimum 5+ years of experience in Medical Writing within the pharmaceutical or CRO industry.
Additional certifications such as AMWA, EMWA, or RAC are advantageous.
Knowledge, Skills & Abilities:
Technical Expertise:
Excellent data interpretation and medical writing skills.
Strong understanding of global regulatory documentation guidelines.
Proficiency in Microsoft Word, PowerPoint, Excel, and document management systems.
Knowledge of preclinical, therapeutic, regulatory submissions, and communication processes.
Project & Communication Skills:
Exceptional project management and organizational abilities.
Strong oral and written communication, editing, and proofreading skills.
Effective interpersonal and negotiation skills.
Ability to work under pressure and meet tight deadlines with high-quality outputs.
Collaborative, results-driven mindset with sound judgment and decision-making skills.
✅ Summary:
This role is ideal for an experienced Medical Writing professional with a strong foundation in Regulatory Affairs and Pharmacovigilance, excellent leadership skills, and a passion for quality and compliance in scientific communication.
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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