LS SCON R&D Business Consulting

• Engage with crossfunctional R&D teamsRegulatory Clinical Operations Medical Writing Safety/Pharmacovigilanceto 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 RIMSeDMSSafetyClinical 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 andinspectionreadiness.

• Partner with safety teams to enableaccurateSafety Case Management data Label updates safety variation submissions and compliance reporting.
• Assistin aligning R&D master data (Product Study Molecule Substance) across Clinical Safety and Regulatory systems.

• GuideIDMP/SPOR/xEVMPDreadiness 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 Safetysuch asRegIntelcrawlers content generation publishing automation safety data ingestion and clinical document processing.

• Collaborate with engineering AI and platform teams to buildproof-of-concept evaluate tools anddemonstratesolutions to clients.

• Serve as a trusted advisor to global R&D leaders bringing structured consulting practices and domain intelligence together.

• Drive PMO activitiesJIRA management sprint planning stakeholder communication RAID logs reporting and release preparation.

• Simplify complex technical topics into clear business recommendations and influence decisionmaking across R&D functions.

• Bachelors/Masters in Life Sciences/Pharmacy/or related

• 5 years in R&D Clinical Research and/or crossfunctional Life Sciences consulting with handson exposure to EDC eTMF CTMS SSU and clinical data/operations.

• Demonstrated ability to analyze/translate business requirements into technical specs collaborate with crossfunctional/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

• Handson 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.

• Proficiencyin 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 worlds 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.