Regulatory Documentation Specialist Jobs

Description:

Responsible for generating templates, tables and figures, and prepare study reports for Local Delivery Translational Sciences (LDTS) and LDSTS teams.

Work with program representatives to establish timelines and coordinate activities to meet timely completion of documents in support of regulatory submissions.

In collaboration with LDTS and LDSTS members prepare, review, and format documents, study protocols, and study reports with high quality and as needed, in accordance with electronic submission requirements.

Responsible for performing detailed authoring and QC of data in reports, and assisting with formatting and quality check of nonclinical sections of regulatory documents (INDs, CTDs, IBs, and others).

May serve as LDTS/LDSTS liaison to the Regulatory Affairs Operations and Medical Writing group to support the establishment of new processes and systems.

Operate with minimal supervision.

Assists LDTS and LDSTS staff with preparation of contributing and final reports, completing assignments.

Assure reports meet departmental standards for formatting, consistency, and adherence to required styles.

Works with study personnel to generate tables and assemble reports that accurately and precisely describe study data.

Coordinates publication and review of LDTS and LDSTS reports and documents.

Common Technical Documents (CTD) tabular summary templates for reports and regulatory submissions.

Performs submission QC for format and accuracy of content and performs technical QC on published submissions.

Facilitates and coordinates assembly, including timelines, of documents for regulatory submissions globally.

Assists in the maintenance of the GLP and Non-GLP study schedule. Issues study and report numbers.

Assists in maintaining regulatory and training records and documents for study personnel.

Electronically distributes study protocols and protocol amendments to study personnel for documentation that they have been read and understood, as requested.

Facilitates formatting, editing, and reviewing departmental procedures (SOPs) for approval by management.

Manages and maintains associated forms and tracking lists for all of LDSTS and LDST.

May serve as a back-up local system administrator (LSA) for key systems used within or by LDTS and LDSTS.

Supports LDTS and LDSTS document administration using laboratory information management systems (LIMS, e.g., Provantis) to generate templates and tables for topline data and prepare nonclinical study reports.

Supports departmental SharePoint sites.

Works with LDST and LDSTS staff to produce protocol and report templates for various document types utilizing automated and/or manual data collections systems.

Establish timelines and coordinate activities to meet timely completion of documents in support of submissions.

Qualifications:

Bachelor’s Degree or equivalent education with 2 years of experience; OR

Master’s degree or equivalent education with 0-2 years of experience

Theoretical and practical knowledge to carry out the job functions

Familiarity with Windows-based platforms, technical authoring, comfort working in a computerized environment, and ability to learn electronic databases and enterprise management software

Excellent oral and written communication skills are required

Proficiency in Microsoft Office and various document management systems

Experience with formatting Word and PDF documents (creating links and assembly)

Technical/scientific writing experience

Experience with Regulatory Submissions of Nonclinical and/or Clinical Modules for multiple countries IND, NDA, CTA, JNDA etc. preferred