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Senior Specialist - Veeva Vault RIM
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.
- Drive and Lead Regulatory Data Quality initiatives and supports definition of data entry guidance.
- Drive to compliance activities in VEEVA Vault
- Contributes to IDMP data management activities - like P, O and R data management & Data Catalogue
- Contributes to training and documentation creation as per data entry guidance and system functionalities in VEEVA Vault
- Partners with Global Regulatory Affairs and other functions, departments and divisions for process and data quality topics as well as IDMP related topics
- Monitors and reports on compliance with the defined data quality standards.
- Participates in data cleansing activities related to data quality initiatives or xEVMPD
- Provides support, training, and end user communication for data management topics.
- Contribute to data verification topics.
- Enable data literacy among users directly or indirectly and contribute to change management & Data Governance among stakeholders.
- Ensures compliance to health authority requirements on data submissions.
- Supports implementation of data governance for Global Regulatory Affairs and beyond
- Ensures adherence to data quality principles for regulatory data in VEEVA Vault
- Contributes to define the strategy of the Regulatory Compliance & Regulatory Information Management Department
- Liaise with Health Authorities on data submission topics (e.g., xEVMPD)
- Basic degree in a scientific discipline or related work experience in the chemical-pharmaceutical industry
- Regulatory information management and pharma IT background
- Good knowledge of current regulatory data standards
- Fluent command of spoken and written English
- At least 8 years of professional experience from a pharmaceutical, service provider or IT industry setting, thereof of least 6 years in Regulatory Affairs
- Experience in Regulatory information management & VEEVA Vault RIM
- Demonstrated practical working experience in regulatory systems (RIMS, VEEVA)
Job specific Competencies & Skills:
- Good understanding of Regulatory Affairs business processes
- Regulatory Information management & VEEVA Vault RIM experience
- Good understanding of VEEVA Vault RIM Data Model
- Results-driven and pragmatic approach to work
- Good organizational skills, self-motivated and proactive
- Meticulous working style and high attitude to quality
- Good stakeholder management and communication skills
- Strong service mentality
- Quick comprehension, good analytical and problem-solving skills.
- Ability to work in a virtual and matrix environment.
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!
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.
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