01
GxP
Required
TRPD-26-06076
Life Sciences Regulatory/Clinical Data Interoperability Architect (GxP, Part 11, HL7/FHIR, MCP)
Senior (8–12 years) life sciences/healthcare domain technologist to design and implement GxP- and 21 CFR Part 11-compliant architectures across regulatory operations and clinical development systems. The role emphasizes interoperability across clinical/biopharma data ecosystems, including CTMS/EDC and imaging archives (PACS/VNA), plus healthcare data normalization (DICOM metadata vectorization via dcm2bq) and standards-based pipelines (ICD-10/CPT, HL7/FHIR). Also requires building secure agent orchestration layers and custom Model Context Protocol (MCP) toolsets for “zero-hallucination” automated medical coding and automated regulatory submission drafting/QC.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Full Time
- Experience
- Minimum 8 years and Maximum 12 years
Role overview
Why This Role Matters.
Senior (8–12 years) life sciences/healthcare domain technologist to design and implement GxP- and 21 CFR Part 11-compliant architectures across regulatory operations and clinical development systems. The role emphasizes interoperability across clinical/biopharma data ecosystems, including CTMS/EDC and imaging archives (PACS/VNA), plus healthcare data normalization (DICOM metadata vectorization via dcm2bq) and standards-based pipelines (ICD-10/CPT, HL7/FHIR). Also requires building secure agent orchestration layers and custom Model Context Protocol (MCP) toolsets for “zero-hallucination” automated medical coding and automated regulatory submission drafting/QC.
Your Impact
Deliver Enterprise Value
Help organisations solve complex business problems through modern technology, consulting expertise and measurable outcomes.
Collaboration
Work Across Teams
Collaborate with consultants, architects, engineers and client stakeholders throughout the project lifecycle.
Growth
Learn Continuously
Gain exposure to enterprise technologies, certifications, mentoring and real-world project experience.
Career Path
Grow With Ubique
Build a long-term consulting career with opportunities to take on greater responsibility and leadership over time.
Responsibilities
What You'll Be Doing.
Every role at Ubique contributes directly to solving meaningful business challenges for our clients.
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
02
21 CFR Part 11
Required
03
Regulatory Operations
Required
04
Regulatory Submissions
Required
05
Automated Submission Drafting
Required
06
QC
Required
07
AROS
Required
08
Clinical Development
Required
09
CTMS
Required
10
EDC
Required
11
Data Federation
Required
12
Protocol Design
Required
13
Patient-to-Trial Matching
Required
14
Computational Biology
Required
15
Virtual Screening
Required
16
Molecular Modeling
Required
17
Bioinformatics Pipelines
Required
18
DICOM
Required
19
dcm2bq
Required
20
PACS
Required
Requirements
Skills & Experience.
We value curiosity, collaboration and continuous learning. If you don't meet every requirement but believe you can make an impact, we'd still love to hear from you.
Essential
Required Qualifications
GxP compliance and regulated system design
21 CFR Part 11 compliant architecture (audit trails, e-signatures, controls)
Regulatory operations systems/automation for submission drafting and QC (AROS or equivalent)
Clinical trial systems knowledge (CTMS, EDC)
Healthcare interoperability standards (HL7 and/or FHIR)
Medical coding standards (ICD-10 and CPT)
DICOM metadata handling and imaging archive integration (PACS/VNA)
Hands-on with dcm2bq for DICOM metadata vectorization
Secure agent orchestration over siloed clinical/biopharma data ecosystems
Model Context Protocol (MCP) toolset development in healthcare contexts
Preferred
Nice to Have
EDC data federation
Protocol design concepts
Patient-to-trial matching concepts
Computational biology/discovery workflows (virtual screening, molecular modeling)
Bioinformatics pipelines
What you'll gain
More Than Just A Job.
We're committed to helping every team member grow professionally, personally and technically while working on meaningful projects.
Global Exposure
Collaborate with international clients and multicultural teams on enterprise programmes.
Continuous Learning
Expand your expertise through mentoring, certifications and hands-on project experience.
Career Growth
Take ownership, develop leadership skills and grow your consulting career over time.
Flexible Working
Hybrid and remote collaboration designed around trust and delivering exceptional outcomes.
People First
Join a supportive culture where collaboration, respect and long-term relationships come first.
Enterprise Projects
Work on meaningful technology initiatives for leading organisations across industries.
Apply
Apply for Life Sciences Regulatory/Clinical Data Interoperability Architect (GxP, Part 11, HL7/FHIR, MCP)
One page, about two minutes. We only ask for what we actually need to have a first conversation.