Job Description:

Senior Regulatory Publishing Specialist










Date:

Jun 18, 2021









Location:

Maryland Heights, MO, United States

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About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Senior Regulatory Publishing Specialist is responsible for providing electronic publishing and submission support to the North America regulatory team. The overall responsibilities include, but are not limited to, performing the electronic publishing, bookmarking, hyperlinking for documents that are then built into eCTD submissions of varying complexity to INDs, DMFs, BLAs, NDAs, and ANDAs. This position will act as the primary publisher for the US Regulatory Affairs CMC team.

Essential Functions

• Format documents according to department guidelines and health authority requirements; format MS Word and Adobe PDF files to a state of submission-readiness


• Perform electronic publishing and bookmarking of documents, build of eCTD submissions/metadata


• Create electronic hyperlinks within and across documents/sections

• Coordinates/plans electronic publishing timelines for specific submissions in collaboration with RA CMC group.


• Works independently to drive publishing process for routine submissions.


• Provides report-or document-level publishing as needed.


• Educates document authors on technical submission formats and lifecycle management


• Implements publishing efficiencies and standardized process efficiencies


• Proactively identifies and escalates publishing issues as necessary.


• Ensures published documents/submission output meets author and health authority expectations


• Manage and maintain correspondence and other records in regulatory tracking system


• Keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality

Requirements

• Bachelor's degree in relevant field of study.


• A minimum of 5 years of direct experience with publishing, compiling, and preparing documents for eCTD submissions.


• Proficiency in use of electronic submission publishing software and applications


• High level knowledge of FDA and ICH regulations governing pharmaceutical document submissions


• Excellent communication, interpersonal, time management, and organizational skills.


• Close attention to detail required.


• Ability to work autonomously under limited direction on multiple projects simultaneously


• Demonstrates a working knowledge of publishing technologies/software.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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Regulatory Affairs, Law, Medical Technologist, Pharmaceutical, Publishing, Legal, Healthcare, Science

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