Title: SME, CDISC & eSubmission Standards
Business Unit: Global Clinical Development
Job Grade: Manager, G10

Location: Hybrid/Remote

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a team-oriented spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

JOB DESCRIPTION:
The CDISC & eSubmission Standards Subject Matter Expert (SME) at the Manager level will provide hands-on expertise for CDISC standards (SDTM, ADaM, Define-XML, Controlled Terminology) and regulatory submission support. This role is a key part of our Biometrics Innovation and Statistical Programming team. The incumbent will support the implementation of internal standards,



provide study-level CDISC guidance, conduct quality reviews of deliverables from CRO partners, and ensure clinical data packages meet inspection-readiness criteria for global health authorities.
In this role, a typical day might include the following:
• Contribute to the development and maintenance of internal CDISC and submission standards, templates, and SOPs for SDTM, ADaM, Define-XML, and Reviewer’s Guides (cSDRG, ADRG).
• Ensure study-level compliance with defined SDTM and ADaM versions. Assist study teams in handling standards exceptions and applying transitioning rules.
• Author, review, and QC study-level specifications, including annotated CRFs (aCRFs), SDTM/ADaM mapping specifications, and variable-level metadata.
• Execute review workflows and checklists for internal and external deliverables. Conduct hands-on review of CRO-provided SDTM, ADaM, Define-XML, and submission data packages.
• Assist in assembling and

📌 SME, CDISC (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram