With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.
Highlights
145548BRNew Jersey, New YorkUSAInfosys Limited Senior Associate - Business ConsultingITL USA Bridgewater, NJ, New York, NYLife SciencesProcess|Consulting processes|Technology Consulting process Senior Consultant- Research and Development, Life Sciences130000177000. 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.
Numbers & Facts
| Location | Bridgewater, NJ |
| Industry | Computer/IT Services |
| Company Size | 10,000 employees or more |
| Website | https://www.infosys.com/careers |
Description
2242967No5439234810.00.004/28/2026LS/ SCON R&D - Business ConsultingSenior 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
145548BRNew Jersey, New YorkUSAInfosys Limited Senior Associate - Business ConsultingITL USA Bridgewater, NJ, New York, NYLife SciencesProcess|Consulting processes|Technology Consulting process Senior Consultant- Research and Development, Life Sciences130000177000
Benefits
Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits:
- Medical/Dental/Vision/Life Insurance
- Long-term/Short-term Disability
- Health and Dependent Care Reimbursement Accounts
- Insurance (Accident, Critical Illness, Hospital Indemnity, Legal)
- 401(k) plan and contributions dependent on salary level
- Paid holidays plus Paid Time Off
About Us
Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world's top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants:
- Ability to design and implement end-to-end solutions at scale
- A flat organization structure with direct access to our senior-most leaders
- An entrepreneurial environment full of bright, highly motivated consultants
- Opportunities for motivated consultants to impact local communities
- The ability to design your career and drive your professional learning and development
- A truly global culture
EEO
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.