Job Information
Replimune, Inc. Manager/Sr. Manager, Regulatory Information Management (RIM) in Woburn, Massachusetts
Overview:
The Sr. Manager Regulatory Information Management (RIM), reports to the Director, Regulatory Affairs Operations and works closely with regulatory, quality, clinical, nonclinical, technical operations team members to enhance and improve RIM capabilities and to ensure data integrity as well as compliance, while overseeing development and delivery of training and training materials,
This position is based in our Woburn office and welcomes hybrid or remote work! Local candidates are expected to be on-site 2 days per week.
Management of RIM Veeva Vault and Connections Vault.
Support the development of procedure documents, and best practices for RIM.
Support RIM users by leveraging top support and value from the Veeva Vault RIM suite of product systems.
Designs, develops, and implements training methodologies that have a positive impact on our team’s culture while ensuring rapid learning from basic to complex RIM functionality.
Support requirements definition, solutioning and implementation.
Communicate with customers on operational support services and requests.
Provide technical solution to address business requirement.
Vault deployment of changes/enhancements across environment.
Manage all user accounts in the RIMS system regarding all user permissions and restrictions and security profiles.
Interfaces with system and users to detect necessary ad hoc regulatory and compliance requirements.
Providing support in software validation, migration, and updates specific to Regulatory Operations systems.
Management of system access and security model.
Maintaining regulatory tracking databases (commitments, health authority comments, etc.) and providing ad hoc reports to regulatory colleagues, when requested.
Identify process challenges and implement process improvements.
Manage issue and change activities and timelines.
Oversee Veeva managed services resources.
Lead and support Regulatory Operations Intelligence related to industry technology platforms and processes.
Monitor emerging electronic standards or health agency requirements, assess business impact and define roadmap for addressing them.
Requirements:
Bachelor’s degree, and 5+ years of experience.
Experience with Veeva Vault RIM is mandatory; Veeva certification desired.
Knowledge of pharmaceutical drug and device development process.
Experience in systems management or implementation in the life sciences industry or regulated industry.
Strong organizational skills.
Critical thinking/problem-solving skills.
Ability to operate in a fast-paced environment and manage multiple activities, priorities, and deadlines.
Excellent verbal and written communication skills.
Excellent training development and delivery skills.
Experience Managing Technology projects (e.g. eDMS, eTMF, tracking systems).
Location Requirements:
This position can be based either in our Woburn office or be a remote role
Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.
Replimune is an equal opportunity employer.
Replimune now requires COVID vaccination disclosure for all US employees.
Requisition ID: 2023-1431
External Company Name: Replimune, Inc.
External Company URL: replimune.com
Street: 500 Unicorn Park Drive