Senior Consultant- Research and Development, Life Sciences
We’re seeking a Senior Consultant who blends R&D domain depth (Clinical, Safety, Regulatory) with consulting excellence (problem framing, stakeholder influence, structured delivery, and thought leadership) for Life Sciences Practice. You will translate complex R&D business needs into scalable processes, data, and platform solutions, enabling efficiencies across Clinical Operations, Pharmacovigilance, and Regulatory while advancing data governance and automation/AI use cases.
This role spans end‑to‑end R&D operations, supporting clients through Regulatory/Clinical/Safety functions while driving impactful system implementations, data‑centric initiatives, and automation programs.
Key Responsibilities
1. R&D Systems & Process Consulting (Regulatory, Clinical & Safety)
- Engage with cross‑functional R&D teams—Regulatory, Clinical Operations, Medical Writing, Safety/Pharmacovigilance—to understand process pain points and define harmonized, scalable solutions.
- Conduct workshops, requirement gathering, business analysis, and process mapping across R&D functions.
- Provide consulting support for Clinical and Safety workflows such as protocol amendments, safety reporting, signal management, CTA/IND submissions, and compliance tracking.
2. Regulatory Information Management (RIMS) & Data Governance
- Lead/support RIMS implementations, upgrades, and enhancements by connecting Regulatory needs with Clinical and Safety data flows.
- Develop RIMS–eDMS–Safety–Clinical interoperability frameworks to ensure consistent product, submission, and registration data.
- Establish data governance operating models across full R&D, defining stewardship roles, data ownership, business rules, and data quality KPIs.
3. Clinical & Safety Data Enablement
- Support configuration and process alignment for Clinical Trial Applications, tracking systems, clinical documentation lifecycles, and inspection readiness.
- Partner with safety teams to enable accurate Safety Case Management data, Label updates, safety variation submissions, and compliance reporting.
- Assist in aligning R&D master data (Product, Study, Molecule, Substance) across Clinical, Safety, and Regulatory systems.
4. IDMP, xEVMPD & Structured Data Across R&D
- Guide IDMP/SPOR/xEVMPD readiness and implement structured data models that align Regulatory, Clinical, and Safety data sources.
- Support automation of IDMP data extraction and mapping from clinical documents, CMC files, safety datasets, and eCTD modules.
5. Regulatory CMC, Publishing & Documentation
- Provide consulting support for CMC variation management, product lifecycle maintenance, change controls, and regulatory strategies.
- Oversee publishing workflows: eCTD compilation, QC, hyperlinking automation, and submission compliance.
6. Digital Transformation, Automation & AI in R&D
- Identify, define, and lead automation initiatives across Regulatory, Clinical, and Safety—such as RegIntel crawlers, content generation, publishing automation, safety data ingestion, and clinical document processing.
- Collaborate with engineering, AI, and platform teams to build proof-of-concept, evaluate tools, and demonstrate solutions to clients.
7. Consulting Excellence & Client Engagement
- Serve as a trusted advisor to global R&D leaders, bringing structured consulting practices and domain intelligence together.
- Drive PMO activities—JIRA management, sprint planning, stakeholder communication, RAID logs, reporting, and release preparation.
- Simplify complex technical topics into clear business recommendations and influence decision‑making across R&D functions.
Required Qualifications
- Bachelor’s/Master’s in Life Sciences/Pharmacy/ or related
- 5 years in R&D Clinical Research and/or cross‑functional Life Sciences consulting with hands‑on exposure to EDC, eTMF, CTMS, SSU and clinical data/operations.
- Demonstrated ability to analyze/translate business requirements into technical specs, collaborate with cross‑functional/technical teams, and drive agile delivery (Scrum/Kanban).
- Practical knowledge across Regulatory (RIMS, Publishing/eCTD, IDMP), Safety/PV (case processing, signal management), and CMC processes.
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Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
Preferred Skills & Tools
- Hands‑on with Veeva (Vault Clinical/RIM), Medidata Rave, Oracle clinical solutions (or equivalents).
- Experience with virtual/decentralized trials, RWD/RWE, site payments, and clinical audits/monitoring.
- Awareness of AI/ML implementation across the clinical research lifecycle and regulatory operations; comfort shaping POCs and scaling.
- Proficiency in JIRA/Confluence, Agile delivery tooling; familiarity with structured content/authoring and documentation standards.
- Strong consulting soft skills: structured communication, facilitation, conflict resolution, influencing without authority, and crisp storytelling.
