Job Title: Principal Medical Writer
Experience Required: 8+ years
Job Type: Full-time
Location: Remote, India
Department: Clinical Research Services
Function: Medical Writing
Job Description:
Functional Role:
Lead the creation and management of complex clinical and regulatory documentation in support of global clinical trials.
Department:
FSP – Functional Service Provider, Clinical Research
Reporting To:
Medical Writing Leadership (Client Dedicated)
Work Location:
Fully Remote (India)
Primary Responsibilities:
Lead the drafting, development, and editing of high-complexity clinical and regulatory documents (e.g., protocols, CSRs).
Collaborate cross-functionally with teams including regulatory affairs, biostatistics, and medical experts.
Ensure adherence to regulatory guidelines (e.g., ICH, EMA, FDA) and company/industry best practices.
Provide strategic input on content planning, document structure, and presentation.
Mentor junior medical writers, reviewing work for scientific accuracy, clarity, and compliance.
Manage multiple writing projects concurrently while maintaining timelines and quality.
Stay up to date with emerging trends in regulatory writing, content automation, and structured content authoring systems.
Education and Experience:
Bachelor’s degree in a scientific discipline is required. Advanced degree (MSc, PhD, PharmD) preferred.
Minimum 8 years of regulatory medical writing experience within a CRO or pharmaceutical environment.
Experience in Phase 3 protocols and clinical study reports (CSRs) required.
Familiarity with EU CTR and structured content management systems (SCMS), natural language generation, and AI-driven content creation is preferred.
Knowledge, Skills, and Abilities:
Expert knowledge of global regulatory writing requirements and clinical trial lifecycle.
Strong leadership and project management capabilities.
Excellent communication and interpersonal skills to interact across global teams.
High attention to detail, independence in decision-making, and strong problem-solving abilities.
Competent in mentoring and guiding junior team members.
Self-driven, adaptive, and quality-focused.
What We Offer:
Competitive salary and extensive employee benefits.
Flexible working culture with a focus on work-life balance.
Access to global learning programs and professional growth opportunities.
Collaborative and innovative team environment.
Opportunity to contribute to global health advancements through meaningful work.
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