Senior Solution Architect – Pharmaceutical / Life Sciences

Job Title: Senior Solution Architect
Experience: 10+ Years
Relevant Experience: 5+ Years as a Solution Architect
Domain: Pharmaceutical / Life Sciences
Location: PA/NJ
Employment Type: W2 only

Job Summary

We are seeking an experienced Senior Solution Architect with strong expertise in Pharmaceutical Development, Regulatory Affairs, Cloud Architecture, Enterprise Integration, and Generative AI.

The ideal candidate should have a solid understanding of pharmaceutical regulatory processes, medical writing, content management, and regulated environments such as GxP, HIPAA, and GDPR.

The candidate will be responsible for designing scalable, cloud-native enterprise solutions and AI-powered workflow automation platforms that support pharmaceutical regulatory operations, advanced analytics, and intelligent automation.

Key Responsibilities

• Design and implement enterprise-level solution architectures for pharmaceutical development and regulatory affairs.

• Understand pharmaceutical regulatory processes, business capabilities, data, content, and industry terminology.

• Architect solutions supporting medical writing, document authoring, and regulatory content management.

• Design and operationalize integrations using REST APIs, Apache Kafka, ETL, API gateways, data pipelines, and data streaming.

• Architect and deploy scalable cloud-native solutions using AWS, Azure, and/or Google Cloud Platform.

• Design cloud infrastructure covering compute, networking, storage, databases, and integrations.

• Develop AI/ML-driven workflow automation solutions using Generative AI, LLMs, and Agentic AI.

• Leverage frameworks such as TensorFlow, PyTorch, or similar technologies to integrate AI capabilities.

• Understand LLM training, fine-tuning, model evaluation, optimization, and deployment.

• Ensure compliance with regulated environments, including GxP, HIPAA, and GDPR.

• Implement appropriate data privacy, security, governance, and compliance controls when using public and enterprise LLMs.

• Translate complex business requirements into technical architecture, solution designs, and implementation roadmaps.

• Lead technical discussions, drive consensus, resolve ambiguities, and collaborate with cross-functional stakeholders.

• Create architectural diagrams, technical documentation, and presentations.

• Design highly available, scalable, flexible solutions supporting multinational users and Health Authority communities.

Required Skills & Qualifications

• 5+ years of experience as a Solution Architect in Pharmaceutical Development.

• 5+ years of experience in enterprise integration architecture and operationalization.

• 5+ years of experience working with Content Management Platforms and structured RDBMS.

• 5+ years of experience architecting and deploying cloud-native solutions on AWS, Azure, and/or Google Cloud Platform.

• Strong understanding of Pharmaceutical Regulatory Affairs, medical writing, and authoring processes.

• Hands-on experience with REST APIs, Kafka, ETL, API gateways, and data pipelines.

• Experience architecting regulated systems such as GxP, HIPAA, and GDPR.

• Knowledge of Generative AI, Machine Learning, LLMs, and Agentic AI.

• Proficiency in TensorFlow, PyTorch, or similar AI/ML frameworks.

• Understanding of LLM training, fine-tuning, model evaluation, and optimization.

• Experience with AI-driven workflow automation and advanced analytics.

• Strong cloud-native solution engineering experience.

• Excellent communication, stakeholder management, and technical leadership skills.

Preferred Qualifications

• Experience in pharmaceutical regulatory submission platforms.

• Knowledge of regulatory content management and document authoring solutions.

• Experience implementing enterprise AI solutions in regulated industries.

• Experience supporting multinational pharmaceutical organizations and Health Authority requirements.

Key Technical Skills

Pharmaceutical Development, Regulatory Affairs, Life Sciences, Medical Writing, Solution Architecture, AWS, Azure, Google Cloud Platform, REST APIs, Kafka, ETL, API Gateway, Data Pipelines, RDBMS, Content Management Systems, GxP, HIPAA, GDPR, Generative AI, LLM, Agentic AI, Machine Learning, TensorFlow, PyTorch, Cloud Architecture, Workflow Automation.