Associate Manager, Clinical Label Mgmt.

Job description

Job Description

Role Purpose:
Plan, coordinate, and perform timely labelling activities for Investigational Medicinal Product (IMP) used in clinical trials. Plays a major role in being a point of contact for the different functions in Global Clinical Supply (GCS) for all label related activities. Ensure compliance of processes with regulations as well as Novartis Standards of Compliance and GxP requirements.

Major Responsibilities/Accountabilities:
• Generates label for IMP and ensures agreed milestones, quality and cost are met.
• Is accountable for label compliance with study and country specific as well as with Novartis Standards of Compliance.
• Is responsible for creation of medication/randomization list/ schedules.
• Manages business administration activities of Clinicopia (Label design application) /Randomization reporting tool (RRT) in SAP.
• Maintains Phrase Library.
• Liaison with external service providers for labelling activities of Investigational Medicinal Product (IMP) used in clinical trials.
• Ensures alignment with all related clinical trial activities (Clinical trial supply mgt. and DRA) to achieve agreed timelines.
• Performs and documents GMP confirm line unit check of labels as defined in SOP.
• Informs Team Head or deputy about quality event i.e. deviation.
• Be responsible for communicating issues to the internal and external stakeholders and negotiate to bring solutions.
• Is able to describe the process and answer question regarding label process during
Internal/external inspections.
• Manages all applicable finance activities, including Grants, Purchase Orders (PO) and invoice approval

Position Title

Associate Manager, Clinical Label Mgmt.

Desired profile

Minimum requirements

Minimum/desirable requirements:
• Pharmacy/Life Sciences Graduate/Post Graduate.
• Fluency in English.
• Minimum 2-3 years of experience in pharmaceutical / clinical research / drug development organization
• Good understanding of Clinical Trials / Drug Development.
• Strong working knowledge of SOPs and compliance.
• Strong influencing and communication skills.
Job Type

Full Time
Country

India
Work Location

Hyderabad
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

TECHNICAL R & D GDD
Employment Type

Regular
Company/Legal Entity

Nov Hltcr Shared Services Ind