Document Control Specialist Iii

Purpose:

This role resides in the documentation team under the Local Delivery Safety Translation Sciences (LDSTS) team. This role is responsible for generating templates, tables and figures, and prepare study reports for Local Delivery Translational Sciences (LDTS) and LDSTS teams. He/She will work with program representatives to establish timelines and coordinate activities to meet timely completion of documents in support of regulatory submissions.

The Regulatory Documentation Specialist, in collaboration with LDTS and LDSTS members, will prepare, review, and format documents, study protocols, and study reports with high quality and as needed, in accordance with electronic submission requirements. This role is also 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).

In addition, the incumbent may serve as LDTS/LDSTS liaison to the Regulatory Affairs Operations & Medical Writing group to support the establishment of new processes and systems.

The individual must operate with minimal supervision. In addition to a scientific background, this position requires 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.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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 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 & 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.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

•Bachelor’s Degree or equivalent education with typically 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.