IW
R&D modernization _ Consultant
Info Way Solutions LLC
- 🇮🇳 India
- On-site
- Manager or above
- 20 hours ago
- Veeva
- AI
- Change Management
- GxP
- Fabric
- CBAP
- PMP
- PRINCE2
20 hours ago
Program Manager and Senior Business Analyst, R&D Modernisation
Domain facing roles across the core areas of R&D
Location:Lupin Research Park, Pune, India
Experience - 8-15 Years
Reports to:Head of R&D IT
Engagement:Programme aligned, typically six to eighteen months per programme, extendable About the role Our R&D function is in the early stages of a digital reimagination, and we are building the capability to run it ourselves rather than have it delivered to us. This role description covers a family of domain facing positions engaged programme by programme, at manager or senior business analyst level depending on scope.
The expectation is the same in every case. The person will do more than gather and translate requirements. They will own the process, understand the underlying science or regulatory practice well enough to challenge and improve it, and partner directly with scientists, clinical teams, quality and regulatory colleagues to redesign how the work flows from end to end. Domain specialisation Each position carries deep specialisation in one of the following core areas. Cross domain exposure is welcome, but depth in the named area is what qualifies a candidate.
- Regulatory.Regulatory information management, structured data and standards, and global submissions across markets, on platforms such as Veeva or ArisGlobal.
- Clinical development.EDC, CTMS, eTMF, and the data flow from protocol through database lock to submission, on platforms such as Veeva, Clinion or IQVIA.
- Formulation and analytical development.ELN, LIMS and laboratory data management on platforms such as Revvity Signals, Biovia or Benchling, chromatography data systems such as Chromeleon, LabX or Empower, and instrument integration.
- Map, challenge and redesign the domain's core processes end to end, and distinguish genuine requirements from established convention before either is carried into a new platform.
- Partner directly with the domain's practitioners, and with quality, regulatory and IT colleagues, earning trust and influencing without direct authority.
- Evaluate technology on its fit for real scientific, clinical and regulatory work rather than on feature lists, supported by a sound business case covering cost, risk, adoption effort and measurable benefit.
- Translate the target process into structured requirements, URS and configuration decisions, and own traceability from user need through configuration to test evidence.
- Own delivery through to measurable adoption, not simply to go live: define what adoption looks like, drive training and change management, and track benefit realisation after release.
- Act as Lupin's advocate with implementation partners and platform vendors, challenging vendor led decisions that do not serve our operational reality, and holding partners to scope, milestones and quality commitments.
- Plan and run user acceptance testing so that test scenarios reflect how the work is actually done, drive defect resolution, and secure formal sign off ahead of each release.
- Coordinate with the data migration and validation workstreams so that requirements, migration and validation evidence stay aligned, and raise risks and dependencies early rather than at milestone.
- Work within a fully GxP environment, ensuring configuration and requirement decisions are documented to support IQ, OQ and PQ activity and a risk based computer software assurance approach, and upholding data integrity under 21 CFR Part 11 and EU Annex 11.
- Partner with our AI, data science and quality functions so that each programme contributes usable, structured data to the wider R&D data foundation rather than another silo.
- Bachelor's or master's degree in a life sciences, pharmacy, chemistry, biotechnology or related scientific discipline.
- Eight years or more in R&D technology within pharmaceutical, biotech, diagnostics or CRO environments
- Genuine domain expertise in one of the three core areas above, deep enough to challenge established practice and to be credible with practitioners.
- Hands on delivery of at least one enterprise platform implementation, migration or upgrade in that domain, from requirements through to adoption.
- Track record implementing systems in a GxP environment, with practical knowledge of validation, UAT in a validated context, and data integrity requirements.
- Experience running requirements workshops with domain stakeholders and authoring documentation that stands up to review and audit.
- Multi-site rollout, training and adoption experience across a scientific, clinical or regulatory user population.
- Vendor and implementation partner management, including the confidence to hold a position with a vendor and the judgement to know when not to.
- Ability to translate between domain language and technology terminology with equal fluency, in front of scientists, quality leadership and IT alike.
- Business case and structured vendor evaluation experience, including scoring, and technical, security and compliance due diligence.
- Data migration from legacy systems, including mapping, reconciliation and archival decisions.
- Exposure to AI or advanced analytics applied to R&D data, and to data foundation or data fabric initiatives.
- Experience of a risk-based computer software assurance approach for SaaS platforms.
- Business analysis or delivery certification such as ECBA, CCBA, CBAP, PMP, PRINCE2, or Certified Scrum Product Owner.
Thanks
Amol
R&D modernization _ Consultant · Info Way Solutions LLC