Senior Level Information Management Specialist Jobs

• This company is implementing Ennov Regulatory Information Management (RIM) as the strategic platform to support regulatory submissions, regulatory correspondence, submission lifecycle management, reporting, workflow automation, integrations, and archival capabilities. Ennov has been selected as the preferred RIM solution following a vendor evaluation process.

• The Solution Architect will be responsible for the end-to-end architecture, design governance, integration strategy, data migration approach, and technical leadership for the implementation of the Ennov RIM platform. The role will work closely with Regulatory Affairs, Quality, Enterprise Architecture, Data, Integration, Security, and Vendor teams to ensure successful deployment and alignment with enterprise standards.

• The RIM platform is expected to enable regulatory registrations, submissions, publishing, archival, workflow automation, and integration of regulatory data across the enterprise

Key Responsibilities:

Solution Architecture & Design:

• Configure master data to support regulatory submission identification, templates and analysis

• Configure submission templates (to accelerate construction of submissions)

• Configure submission workflow templates (to assure routing for review and approval in the most efficient manner)

• Configure supporting templates and workflows, such as Regulatory Correspondence

• Configure submission archiving

• Deliver reporting and dashboards for both master data and the submissions process (dashboards)

• Deliver integration to support Master Data updates

• Deliver integration to support submissions development (e.g. data files, studies reports)

• Perform data migration of in-scope completed submissions, attaching migrated submissions to appropriate master data and disposition

Experience:

• 10+ years of enterprise application architecture experience.

• 5+ years as Solution Architect for enterprise software implementations.

Prior experience implementing:

• Regulatory Information Management (RIM)

• Regulatory Affairs applications

• Quality Management Systems

• Clinical or Life Sciences platforms

Regulatory Domain Experience

Strong understanding of:

• Regulatory Affairs processes

• Submission management

• Product registrations

• Regulatory correspondence

• Submission publishing

• Regulatory archives

The pay range that the employer in good faith reasonably expects to pay for this position is $34.67/hour - $54.18/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.