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 2. Regulatory Information Management (RIMS) & Data Governance 3. Clinical & Safety Data Enablement 5. Regulatory CMC, Publishing & Documentation 6. Digital Transformation, Automation & AI in R&D 7. Consulting Excellence & Client Engagement Required Qualifications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
  
  

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.