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Associate License Management

1.00 to 3.00 Years   Bangalore   13 Mar, 2023
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

    Archive and store regulatory communications (internal or external)Archive documentationPerform data entries and updates (e.g. RIMS)Archive in eDMS/ local document repository Execute initiatives to ensure regulatory compliance, as requiredAlign with other functions (e.g. GPS) for compliance report requirementsMonitor and track submissions and approvalsPrepare and distribute status reports as required To provide any other ad-hoc support to activities executed at REC, envisaging that:-Relevant training has been successfully completed upfront-The necessary regulatory, system, product or process knowledge has been provided-Skills and competencies required for the ad-hoc tasks completion are in line with the agreed REC skill setSuch additional allocation may be an element of individual development plans or a contribution to the business continuity of the organisationJob specific Competencies & Skills Management and Planning: Ability to execute assigned tasks with support from team lead/mentor. Adherence to agreed timelines and proactive communication of any risk for the same. Provide high quality deliverables as per company standards. Fully trained in related systems and databases (APT, Trackers, RIMS, EDMS). Understands the contribution of own work to the organizations value chain and demonstrates creation of customer value. Shall anticipate opportunities and invest in learning about technologies in own area. Communication and Collaboration: Excellent written and spoken English language. Demonstrates proficiency in day-to-day business communication. Demonstrates proficiency in compiling and delivering presentations to a target group of people within the own area of specialization/ project environment. Consistently takes an active role in networking activities within own area of specialization/ project environment. Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes). Recognizes other s point of view and makes sure that everyone is listened to and understood. Pursues active networking across disciplines/ areas, projects. Systems and Applications: User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint). User has contributor level of experience with RIMS and EDMS RA application. Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision require,

Keyskills :
regulatory affairsbusiness continuityregulatory complianceregulatory guidelines

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