RIM Specialist

Job Purpose:

The RIM specialist supports and manages requests for the business application owner of Veeva Submissions and Submissions Archive, which includes customizing the system to meet shifting business needs. Additional responsibility will include testing and releasing periodic system updates from Veeva.

The RIM specialist will work in collaboration with the business, Quality, and IT to triage, fix and address change controls, system issues and training issues. The ideal candidate will have experience authoring GxP Change control documentation along with providing support in validation testing of the application to support the configuration and maintenance activities for Veeva Vault RIM.

Duties and Responsibilities:

• Providing global support covering all issues related to Veeva Vault RIM (Submissions and Submissions Archive)
• Learning everything about our Veeva platform and use that knowledge to ensure client success
• Troubleshooting critical production issues affecting end-users, including system unavailability and data integrity issues
• Handling inquiries regarding all technical issues, information requests on application capabilities, navigation, installation, or configuration
• Providing coordinated support for getting new releases and configuration changes into production
• Gathering information for analysis, conduct the necessary research, setup test environments, replicate issues locally and propose resolutions or workarounds
• Being a client facing representative of the Development and Product teams
• Documenting new processes and keep existing documentation and tools up to date as the environment changes
• Interfacing with product management and professional services when necessary
• Attending meetings and provide status updates

Qualifications:

• Bachelor’s degree (preferred) or 5 years related experience
• Extensive experience configuring Veeva Vault RIM and providing end user support
• Proficiency in Microsoft office suite (Word, Excel, Project) and Adobe Acrobat
• Advanced experience configuring Veeva RIM Submissions and Submissions Archive
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Proven ability to think flexibly to meet constantly shifting priorities and timelines.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Willingness to learn new skills and information that improve our regulatory operational capabilities
• Sense of urgency and ability to work well in high pressure / high stress situations

Working conditions:

This position is largely sedentary. There is an expectation of on-site presence at Ocugen’s Malvern, PA headquarters once per month.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.