September 2026

Serves as a Clinical Data Reviewer and identify any errors in data by performing data review per DRP and issuing/closing queries.

Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business.

Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.

Responsible for preparing lower complexity documents such as synoptic or abbreviated CSRs under guidance of more senior staff. Assist Medical Writers in the preparation and background writing of clinical study protocols, CSRs, and subject narratives.

Senior Principal Consultant - Validation leads enterprise‑level validation strategy by shaping frameworks, harmonizing standards across portfolios, and ensuring global regulatory compliance while driving high‑risk programs, organizational capability building, and long‑term CSV transformation with executive stakeholders.

Contributes, with appropriate oversight, to all relevant aspects of global clinical trial activities to deliver study outcomes within schedule, budget, quality, compliance and performance standards. May lead specific aspects of global clinical trial. High quality contributions to study documents e.g. protocol, ICF, clinical sections of CTA -Clearly demonstrates Novartis Values and Behaviors i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.

Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision.

Performs E2E process related scientific writing that includes but not limited to manage workflow in PubConnect, create publication plan, author approvals, pre-submission queries, submission activities etc.

Alkem Laboratories Ltd. has announced the launch of Renocia Exo™, a next-generation hair regeneration therapy designed to support hair follicle health and vitality through a multi-targeted approach to hair loss management. The company describes the product as India’s first patented ginsenoside exosome-based hair growth serum.