Job Description:
R&D Systems Managers work with global business partners to understand technology needs, ensure compliance and representative of cross functional business processes.
Key Responsibilities:
* Provide strong working knowledge of digital capabilities used to support global R&D business processes.
* Understand CMC, medical devices and regulatory processes and identify health authority trends and policies that could impact current systems.
* Monitor emerging global health authority requirements to assess business and system impact including developing and implementing requirements to ensure compliance.
* Collaborate with key business users to identify business needs and translate these needs to user requirements.
* Translate user requirements into technical requirements and implement solutions to meet requirements.
* Provide business analysis techniques including business and functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis.
* Successfully manage IT projects for R&D to implementation by coordinating activities of project personnel to ensure the project successfully delivers in scope, on schedule and within budget.
* Support project execution tasks to configure, integrate and migrate Veeva RIM Registrations and Submissions Vaults.
Required Skills and Qualifications:
* Bachelor's degree in a science, IT or a related field.
* Advanced degrees are a plus.
* Prior experience in the pharmaceutical industry and a strong understanding of global R&D CMC, Medical Devices & Regulatory Affairs business processes.
* Experience with validated GxP environments, including Implementation, documentation, and Change Management is necessary.
* Hands-on experience implementing, configuring and integrating Veeva Vault RIM platform including Registration, Submissions & Archive Vaults.
* Veeva certification desired.
* Broad technical knowledge, including experience with SaaS in a regulated environment.
* Experience in business processes for CMC, medical devices and for regulatory submission planning and tracking, registration management, commitment management and content management.
* Strong business analysis and project management skills as well as attention to detail.
* Ability to operate in a dynamic challenging environment and manage multiple activities, priorities, and deadlines.
* Excellent verbal and written communication skills.
* Works well in and appreciates the value of a global diverse work environment.
* Is able to see the larger picture and able to identify and successfully communicate key issues in complex situations.
Benefits:
* Competitive salaries.
* Inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
* Excellent career progression opportunities.
* Work-life balance initiatives.
Diversity and Inclusion at Our Company:
We are dedicated to building a truly diverse, inclusive and authentic workplace. If you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply.