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Form der Arbeit- Careers
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Posted 20 Mar 2024
Bangalore, Karnataka - India
Req Id 273086
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Your Role:
Accountability/Interdependence:
• Support regulatory & Data Quality initiatives and manage definition of data entry guidance’s.
• Support in VEEVA Release management activities
• Contributes IDMP data management activities - like O and R data management
• Perform Text mining activities and operations
• Responsible for the training and documentation creation as per data entry guidance’s and systems functionalities
• Partners with Global Regulatory Affairs and other functions, departments and divisions for process and data quality topics as well as IDMP related topics
• Proactively monitor and analyze data quality, identify and address potential issues, and report on compliance
• Contribute in the data cleansing activities related to data quality initiatives, data migrations or xEVMPD
• Support in the training and end user communication for data management topics
• Ensure compliance to health authority requirements on data submissions
Impact:
• Supports implementation of data governance for Global Regulatory Affairs and beyond
• Ensures adherence to data quality principles for regulatory data in VEEVA Vault
• Support to define the strategy of the Regulatory Compliance & Regulatory Information Management Department
• Independently manage interactions with Health Authorities on data submission topics (e.g. xEVMPD)
Complexity:
• Supports cross-functional or cross-business projects and strategic initiatives
Cooperation:
Internally:
• All functions within RQS
• All functions across R&D contributing to regulatory data and information
• All functions within Healthcare contributing to regulatory data and information
Externally:
• Interaction with regulatory agencies (esp. EMA) for data-focused discussions about e.g. xEVMPD compliance
• Global Regulatory Partners
• Other External Partners
Who you are:
Education:
• Degree in a Life Science or a related discipline, preferably MSc or education in Regulatory Affairs
Work Experience:
• 3-6 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role
• Minimum 4 years of Regulatory affairs experience
Job specific Competencies & Skills:
• Leadership: No specific skills expected
• 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 standards. Fully trained in related systems and databases (Trackers, RIMS/Veeva). 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/Veeva RA application. Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required. The output of the user will usually undergo standard QC/spot check procedure.
• Regulatory Expertise: General knowledge about Regulatory Affairs and specifically IDMP, Regulatory Information Management experience. Good understanding and practical working experience in both processes (e.g. xEVMPD, IDMP) and systems (e.g. RIMS/Veeva). Ability to review and interpret regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.
• Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details.
We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
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