Lead consultant- Labelling
Lead consultant- Labelling
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Job Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125000 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 Lead consultant Labelling
In this role you will be expected to work on deadlines in a fairly highpressure business environment while being a good great teammate.
Ability to work well in crossfunctional teams exhibiting a combination of active listening skills and the confidence to guide decisionmaking 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!
Minimum qualifications
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
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race color religion or belief sex age national origin citizenship status marital status military/veteran status genetic information sexual orientation gender identity physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity customer focus and innovation. Get to know us at www.genpact and on X Facebook LinkedIn and YouTube.
Furthermore please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit paying to apply or purchasing equipment or training.
Required Experience:
Contract
Employment Type
Full-Time
