Specialist Regulatory Information Management

Tarrytown, NY 10591

Posted: 05/31/2019 Industry: Biotech/R&D/Science Job Number: 48959

Specialist Regulatory Information Management

 

Summary:

Responsible for tracking and archiving of Clinical Trial (CT) application regulatory submissions and related deliverables.
Requires some guidance from direct manager.
Functions as a contributor as needed.
Provides support and backup to management as needed.


Job Duties:

Responsible for tracking Clinical Trial (CT) country regulatory submission deliverables including health authority correspondences and approval letters.

Manage and oversee CTA regulatory submission/document transfers between sponsor company  and CROs.

Collect, upload and manage all Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within Veeva Vault RIM document repository. Similarly manage Partner submission exchange.
Archives (categorizing and classifying information) all Regulatory records pertaining to Regulatory Applications (CTA), maintaining Regulatory application indexes, tracking of regulatory documents, and assisting with special projects as needed.

Supports development of procedure documents, or best practices for RIM

Collaborates with the functional area team and key stakeholders

Communicates key RIM-related information to consumers, collects feedback, and takes action

Assists with audit and inspection activities including retrieval of Regulatory information

Assists RIM Training team with developing RIM-specific training on how to effectively access Regulatory information

Assists data steward(s) with implementing data standards to facilitate data quality within RIM systems



Requirements:

Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).

Knowledge and practical experience in managing global Clinical Trial Applications (e.g. IMPD)

Knowledge of pharmaceutical drug and device development process.

Project management experience preferred.

Effective planning, organizational and interpersonal skills.

Experience in Regulatory Affairs/Operations/information.

Thorough knowledge and practical experience with RIM technologies

Knowledge of scientific industry terminology

Strong knowledge of categorization and classifying information

Ability to manage, and/or contribute to multiple ongoing projects simultaneously

Ability to manage, and/or contribute to improvement initiatives

Strong knowledge of technical writing is required

Ability to engage and influence a variety of stakeholders at all organizational levels required
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, Microsoft Office suite, and Adobe Acrobat are required.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills

5 - 8 Years

Victoria Gatarz

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