Labelling-Manager Job in Genpact at Hyderabad
- Genpact
- 3 to 7 Yrs
- Hyderabad
- 1 month ago
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Job Description
- Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI. Inviting applications for the role of Labelling- Manager In this role, you will be expected to work on deadlines, in a fairly high-pressure business environment while being a good great teammate. Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Responsibilities Responsible for executing the content management of core data sheet (CDS) and local product documents (LPDs) Responsible for updating as per the local safety signals Keep up to date with regional labeling regulations Authoring labelling submission package Coordinate and preparation of translation in Local language Creation of gap analysis of the local labels and providing references of supportive literature and publications for the updated text Proofread documents prepared by team Qualifications we seek in you! Masters in Lifesciences or equivalent with experience in regulatory Affairs/Labelling or equivalent Knowledge of the principles and concepts of Labelling, knowledge of the principles and concepts of Labelling, including generics, authorized generics, private labels, device/combination products, how to read and interpret HA regulations and guidance, and underlying SOPs Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions Must be able to construct a Company Response (MAH response) for health authority questions Preferred qualifications Excellent communication and PC skills JobManager Primary LocationIndia-Hyderabad ScheduleFull-time Education LevelBachelor's / Graduation / Equivalent Job PostingFeb 26, 2025, 6:54:09 AM Unposting DateOngoing Master Skills ListOperations Job CategoryFull Time,
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Not Specified
Functional Area: Not Specified
Role/Responsibilies: Labelling-Manager Job in Genpact at Hyderabad
Contact Details:
Company: GenpactLocation(s): Hyderabad
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Keyskills: Content Management Regulatory Affairs Translation Proofreading Communication Skills
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