Overview
We are looking for an experienced leader in medical writing and content authoring to drive strategic initiatives across regulatory, clinical, and AI enabled document authoring. This role will partner closely with client leadership, product, and technology teams to transform authoring capabilities through process, operating model, and digital innovation.
Key Responsibilities
- Lead delivery of complex medical writing and document authoring initiatives across regulatory and clinical domains
- Serve as a subject matter expert guiding teams and clients on document structure, quality, and regulatory expectations
- Engage with senior client stakeholders to shape authoring strategies and drive transformation
- Define and document business and functional requirements for authoring solutions
- Collaborate with product, technology, and AI teams to design compliant solutions
- Ensure outputs align with global regulatory standards including FDA, EMA, ICH
- Drive AI enabled and automated content authoring initiatives
- Mentor team members on medical writing and solution design
Required Expertise
;
15+ years experience in Medical Writing Authoring
- Deep expertise in regulatory and clinical medical writing
- Experience with CSRs, protocols, IBs, labels, and submission dossiers
Executive Stakeholder Engagement
- Ability to influence senior stakeholders and drive transformation discussions
Regulatory Compliance
- Robust knowledge of FDA, EMA, ICH frameworks
Preferred Capabilities
Solution Design Business Analysis
- Experience in requirements gathering and workflow design
Technology AI Enabled Authoring
- Exposure to structured content, NLP, GenAI, and automation
Qualifications
- Advanced degree in Life Sciences, Clinical Research, or related field
- Extensive experience in life sciences consulting or pharma
How youll grow:
- Cross-functional skills development custom learning pathways
- Milestone training programs aligned to career progression opportunities
- Internal mobility paths that empower growth via s-curves, individual contribution and role expansions
📌 Associate Principal (Bengaluru)
🏢 ZS
📍 Bengaluru