29 Aug
|
Novartis
|
Hyderabad
29 Aug
Novartis
Hyderabad
Job Description Summary
As an Integration Operational Manager working across non-GxP and GxP environments, you will support the integration of M&A; activities and asset acquisitions across all modalities. You will work closely with a dedicated team, including PKS Expert and its SMEs (BA, ADME, …) and a BR Line Function Integration Lead, to drive key operational activities. These include facilitating scientific deep dives and gap analyses, managing inventories of studies, study samples, reference substances, critical reagents, e-data, and raw data archives, and supporting the review of business partners, contracts, and invoices. Under the supervision of the PKS Integration Ops Lead, you will manage several M&A; and asset integrations in parallel while maintaining clear and consistent communication with your line manager. This role is critical to ensuring the seamless integration of acquired assets into the Novartis BioMedical Research PharmacoKinetic Sciences (PKS) department.
Job Description
Key Responsibilities
Guide and support the PKS subteam on the integration process
Review of relevant documents ( BioA, ADME etc… )
Bioanalytical reports (MVR, TKR, BDR, IG, analytical plans).
Prepare the "FDA" tabulated summaries and highlight missing validation steps and gaps
Work on the inventories of studies, study samples, drug, reference substances and critical reagents, work closely with the BA SME to provide recommendations on what needs to be transferred to Novartis.
Get a explicit understanding about the nature, volume and current location of the raw data.
Contribute to data transfer to Novartis repositories
Contribute to Source Data Verification
Liaise with Biomedical Research integration office representative
Liaise with Procurement, IT, Legal and other LF related to M&A;
Essential Requirements
PhD with at least 3 years of industry experience, or a master’s degree with at least 6 years of industry experience, in biochemistry, chemistry, pharmaceutical sciences, or a relate
📌 PKS Integration Operations Manager (Hyderabad)
🏢 Novartis
📍 Hyderabad