- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies.
- Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing, and QC.
- Publishes electronic submissions in Electronic Common Technical Document (eCTD) for FDA. This may include source document formatting, internal and external hyperlinking, and bookmarks and sequence-level publishing.
- Support optimization of publishing best practices and submission standards in accordance with regulatory requirements.
- Compiles all materials required in submissions, license renewal, and annual registrations.
- Prepare, publish, and submit regulatory dossiers to FDA.
- Keeps abreast of regulatory procedures and changes. May directly interact with regulatory agencies on defined matters.
- Responsible for the timely completion of assigned publishing tasks.
- Supports the implementation, maintenance, and continuous improvement of authoring and publishing systems and processes striving for publishing excellence.
- Provides training to new users on company templates, authoring software, and internal standards.
- Supports regulatory operations tasks that may not be related to publishing as approved or assigned by the Regulatory Operations lead.
- Bachelors Degree, preferably in a scientific field such as biochemistry or biology, or relevant experience may be substituted
- At least 5 years in a regulatory publishing function.
- Extensive experience with Microsoft Word and Starting Point templates to prepare technical documents.
- Understanding of publishing practices and related issues.
- Direct hands-on experience with the successful submission of eCTD dossiers.
- Previous GlobalSubmit and Veeva experience are required.
- Understanding of global submission requirements (paper standards, CD-ROM, etc.) is desired.
- Knowledge of CDISC (ADaM, SEND, SDTM).
- Understanding of publishing systems and IT system validation and testing practices.
- Experience with electronic document management systems.
- Demonstrated ability to be productive and successful in an intense work environment.
- Competencies: Verbal and Written Communication skills, Proofreading, Editing, Interpersonal skills, Adaptability, Organizational skills, Prioritization and Project Management skills, Cross-Functional Team focus
- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Infrequent overnight travel may occur.
- This position is based in Xeris Chicago office and requires a minimum of three days per week in the office.
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Regulatory Publishing Specialist - Chicago, United States - Xeris Pharmaceuticals, Inc.
Description
Overview:
The Regulatory Publishing Specialist is responsible for the formatting, publishing (PDF), eCTD compilation, review, and dispatch of regulatory submissions to Health Authorities within required timeframes for all Company applications. The Regulatory Publishing Specialist will work collaboratively with the Regulatory Affairs team along with project teams and other functional areas to ensure high quality submission content. This is an individual contributor position, reporting to the Sr. Manager of Regulatory Operations.
Responsibilities:Working Conditions
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
