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Publishing • usa

Last updated: 21 hours ago

Manager, Regulatory Publishing

KMR Search GroupWhite Plains, NY, United States
Full-time

Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments... Show more

Regulatory Submission Publishing Specialist

Compass ConsultingPleasanton, CA, US
Full-time
Quick Apply

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.We are seeking a Regulatory Submission Publishing ... Show more

 • New!

Director of Publishing

Center for Responsive SchoolsTurners Falls, MA, United States
Full-time

Center for Responsive Schools is a K-12 publisher.Reporting to the President and CEO, the Director of Publishing is responsible for providing leadership for CRS's Publishing House and ensuring fide... Show more

Regulatory Submission Publishing Specialist

System One Holdings, LLCPleasanton, CA, United States
$23.46 hourly
Part-time

Regulatory Submission Publishing Specialist.Location: Pleasanton, CA Type: Contract Compensation: $23.Work Model: Remote offsite Hours: Flexible days, part time (24-32 hours/week) Security Clearan... Show more

Accounting Manager, Amazon Publishing Accounting

Amazon.com Services LLCCulver City, California, USA
Full-time

Come support the global growth of Amazon Publishing, creating original content for our global customers! Amazon Publishing Accounting is looking for a highly motivated and curious Accounting Manage... Show more

Music Publishing Manager (Bilingual)

Oregon Catholic PressLake Oswego, Oregon
$79,300.00 yearly
Full-time

Job Type Full-time Description.A candidate based in the Portland metro area is strongly preferred for this role.This full-time position will have a standard Monday-Friday working schedule.OCP is a ... Show more

Publishing Manager (Hybrid)

HybridJersey City, NJ, United States
Full-time

The Publishing Manager will oversee site operations primarily related to the trading metadata that makes up the displays, navigation and other customer-facing features related to trading-based cont... Show more

Production Manager, Publishing

Paramount GlobalNew York, NY, United States
$85,000.00 yearly
Full-time

Production Manager, Publishing.On a mission to unleash the power of content you in? We've got the brands, we've got the stars, we've got the power to achieve our mission to entertain the planet no... Show more

Publishing Associate

Global Channel ManagementBoston, MA, United States
Full-time

Boston, Massachusetts, United States.Publishing Associate needs 2+ years of educational publishing experience, or relevant equivalent experience.Publishing Associate requires:.Excellent written and... Show more

Publishing Producer

2KAustin, TX, United States
$108,900.00–$160,000.00 yearly
Full-time

Founded in 2005, 2K Games is a global video game company, publishing titles developed by some of the most influential game development studios in the world.Our studios are responsible for developin... Show more

Book Publishing Internship

Andrews McMeel UniversalKansas City, MO, United States
$17.00 hourly
Internship

Andrews McMeel Universal is a global, independent, integrated media company providing comics, illustrated humor, and inspirational content across syndication, book, calendar, and greeting card publ... Show more

Regulatory Publishing Manager I

AequorPiscataway, NJ, United States
Full-time

Regulatory Publishing Manager I.Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing.Thi... Show more

TRPG Publishing Lead - D&D

HasbroRenton, WA, United States
$150,500.00 yearly
Full-time

Renton, Washington, United States.We're looking for curious adventurers ready to find their party, fueled by imagination and drive to build what's never been built before.At Hasbro and Wizards of t... Show more

Coordinator, Publishing Services - The Orchard

Sony Music Global Job BoardNew York, NY, United States
$48,000.00 yearly
Full-time

Coordinator, Publishing Services - The Orchard.The Orchard is a leading global music distributor and Artist & Label services company operating in 50+ markets worldwide.The Orchard empowers creators... Show more

Publishing Manager (Hybrid)

Caesars EntertainmentLas Vegas, NV, United States
Full-time

The Publishing Manager will oversee site operations primarily related to the trading metadata that makes up the displays, navigation and other customer-facing features related to trading-based cont... Show more

Associate Editor- Disney Publishing

Disney ExperiencesCELEBRATION, Florida, United States
$51,500.00 yearly
Full-time

At Disney, storytelling is at the heart of everything we do.From beloved classics to today's most iconic franchises, Disney Publishing Worldwide (DPW) creates stories that inspire imagination, spar... Show more

 • Promoted

VP of Publishing & Marketing

CheckbookWashington, DC, USA
$200,000.00 yearly
Full-time
Quick Apply

For 50 years, Consumers' Checkbook has helped people cut through marketing hype and make confident decisions about the doctors, dentists, contractors, and services they trust with their money, thei... Show more

FlatWorld Publishing Sales Representative

FlatWorldUS
$55.00 hourly
Remote
Full-time
Quick Apply

This is a general job posting as we are always hiring! If you think you'd be a fit for the role please do not hesitate to apply.If we have a vacancy in a territory we will follow up to conduct an ... Show more

A&R Publishing Coordinator

Artist Partner Group | Artist Publishing GroupLos Angeles, CA, US
$19.00 hourly
Full-time

APG is an independent new-model label and music publisher.Led by veteran music executive Mike Caren, APG is a well-funded label / publisher with the agility of an indie and the muscle of a major.Th... Show more

PC Publishing & PR Manager - Games

ByteDanceSeattle, WA, United States
$133,950.00 yearly
Full-time

PC Publishing & PR Manager - Games.About the Team ONE Studio, with teams in Shenzhen, Beijing, and Shanghai, oversees the distribution and long-term operation of ByteDance's self-developed and lice... Show more

Manager, Regulatory Publishing

Manager, Regulatory Publishing

KMR Search GroupWhite Plains, NY, United States
30+ days ago
Job type
  • Full-time
Job description

Job Title

Industry Regulatory Affairs

Job Type FT-Days

State/Province New York

City White Plains

Salary $80,000 - $110,000

Job Opening ID ZR_671_JOB

Job Description

Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Job Duties

  • Manages staff who electronically format, publish electronic documents and builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
  • Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
  • Provides guidance on good documentation and submission practices
  • Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
  • Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions
  • Assists with regulatory inspection activities
  • Provide Document authoring template training.
  • Maintains Authoring Template Library and works with cross-functional teams to develop and maintain templates
  • Collaborates with vendors who support Regulatory operations related tasks.
  • Communicates the need for additional resources to management as needed.
  • Requires to function as a contributor as needed.
  • Provides support and backup to management as needed.

Job Requirements

  • Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
  • Working knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.