Senior Specialist, Digital Reg Docs Tech Lead

Job Description

Senior Specialist, Digital Reg Docs Tech Lead

The Opportunity

Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.

Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Our Technology Centres focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company’s IT operating model, Tech Centres are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Centre helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centres.

Role Overview

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help R&D global users to be more productive and enable innovation.

A Sr. GenAI Software Engineer will redefine the “art of the possible” and unleash the potential of the modern technical stack by developing and testing GenAI software solutions and integrating them with our company’s R&D enterprise applications. 

A GenAI Software Engineer with a strong Data Science focus will design, build, and maintain production generative AI systems and data pipelines. You will own end-to-end model integration, data engineering, and application development, mentor engineers and data scientists, and help define architecture, ML Ops practices, and governance for secure, scalable AI solutions in a regulated environment.

What will you do in this role

Develop a strong understanding of our company’s biopharmaceutical R&D business processes, systems, and data, with a focus on clinical, regulatory & pharmacovigilance processes. 

Collaborate with cross-functional teams, including business technology partners, product managers, data scientists, and software engineers, to understand data & system requirements.

Be a role model by creating a culture of curiosity, learning, building, and experimentation.

Conduct ongoing market research and technology assessments to identify emerging industry trends and help align these with the enterprise roadmap.

Ensure that industry-accepted system architecture principles, standards, guidelines, and concepts are integrated with those of allied domains, and coordinated roll-out and adoption strategies are in place. 

Develops a library of deployable and documented design patterns and reference architectures

Design, implement, and maintain generative AI solutions (LLMs, retrieval-augmented generation, embeddings, instruction-following models) to support regulatory document authoring use cases.

Apply prompt engineering, instruction design, template strategies, and fine-tuning/adapter approaches to improve model performance and safety.

Implement retrieval approaches (vector stores, semantic search) and optimize embeddings, index strategies, and relevance tuning.

Build and maintain data pipelines, ETL processes.

Integrate models and AI services into web applications and backend systems (APIs, microservices).

Develop and deploy model-serving infrastructure and ML Ops workflows (CI/CD for models, monitoring, model versioning, reproducibility).

Ensure data quality, privacy, and compliance (GxP-aware where applicable) across model training and inference.

Collaborate with product, UX, and cross-functional teams to translate data science requirements into robust production systems.

Mentor data scientists and engineers; contribute to best practices, design patterns, and documentation.

What should you have

Primary Skills

Generative AI, Large Language Models (LLMs), Retrieval‑Augmented Generation (RAG), Prompt Engineering, Instruction Tuning, Fine‑Tuning / Adapters, Embeddings, Vector Databases, Semantic Search, Python, Machine Learning, Deep Learning, AI Model Development, Data Science, Data Pipelines, ETL, MLOps, Model Serving, Model Deployment, Model CI/CD, Backend Development, APIs, Microservices, AWS, Docker, Kubernetes

Secondary Skills

Regulatory Document Systems, Clinical Systems, Regulatory Systems, Pharmacovigilance Systems, GxP, GxP Compliance, Data Governance, Data Privacy, Secure Data Handling, Hugging Face, PyTorch, TensorFlow, Airflow, Prefect, dbt, Feature Stores, Model Monitoring, Model Versioning, Reproducibility, System Architecture, Reference Architectures, Design Patterns, Prompt Evaluation, Red‑Team Testing, Model Explainability, TypeScript, React, Git, Life Sciences, Pharma Domain

Required Qualifications and Skills:

Bachelor’s degree in computer science, Information Technology, or any Technology Stream, or equivalent relevant experience

7+ years software engineering experience with hands-on experience in AI/ML systems and data engineering.

Strong experience with generative AI technologies: LLMs, embeddings, RAG, fine-tuning, instruction tuning, or adapters.

Proficiency with Python and ML frameworks (PyTorch, TensorFlow, Hugging Face Transformers, or equivalent).

Experience building data pipelines (Airflow, Prefect, dbt, or similar) and working with feature stores or data marts.

Experience with vector databases and semantic search technologies.

Familiarity with model serving and ML Ops tools and model CI/CD practices.

Strong backend development skills (APIs, microservices)

Experience with cloud platforms (AWS preferred) and container orchestration (Docker, Kubernetes).

Solid understanding of data governance, privacy, and secure handling of sensitive datasets.

Proficiency with Git and collaborative development workflows.

Strong communication skills, analytical mindset, and experience working across distributed teams.

Preferred Qualifications and Skills:

Experience in pharma, clinical, regulatory, or pharmacovigilance domains and GxP/regulatory-compliant AI deployments.

Experience with prompt evaluation frameworks, red-team testing, adversarial prompting, or model explainability tools.

Experience with TypeScript/React for integrating AI features into UIs or developer tools.

Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for lives, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

#HYDIT2025

Required Skills:

Data Engineering, Data Visualization, Design Applications, Software Configurations, Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, System Integration, Testing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/9/2026

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