Publishing Coordinator & Team lead @ ProductLife Group | Jobright.ai
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ProductLife Group · 6 hours ago

Publishing Coordinator & Team lead

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level, Lead/Staff
date10+ years exp
ftfMaximize your interview chances
Document ManagementInformation Services

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Responsibilities

Manage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to the applicable regulatory authority (FDA/HC) in compliance with required timelines and specifications.
Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.
Perform document management tasks and post-submission activities including file transfer, tracking, database updates and archival.
Maintain current knowledge of FDA, HC, and ICH requirements for regulatory submissions, and ensure compliance accordingly.
Collaborate with global functional areas to ensure submission-related deliverables are met to achieve strategic business goals.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ECTD publishingRegulatory submissionsAdobe ProEDMS SystemsECTDManagerLife Sciences degreeRegulatory Affairs KnowledgeQuality control proceduresDocument management

Required

Manage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to the applicable regulatory authority (FDA/HC) in compliance with required timelines and specifications.
Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.
Perform document management tasks and post-submission activities including file transfer, tracking, database updates and archival.
Maintain current knowledge of FDA, HC, and ICH requirements for regulatory submissions, and ensure compliance accordingly.
Collaborate with global functional areas to ensure submission-related deliverables are met to achieve strategic business goals.
Bachelor’s degree in Life Sciences or related field
10+ years of experience in eCTD publishing.
Publishing in eCTD, NeeS, ePaper and ACTD formats for EU, US, CA, AU, GCC, ASEAN and other regions.
Coordination and planning of projects that are assigned.
Publish submissions in eCTD and Nees format.
PDF editing in Adobe Pro, ISI toolbox/evermap (bookmarks, TOC, hyperlinks etc).
Use of publishing tools (eCTDManager preferred).
Comfortable in using eDMS Systems.

Preferred

RA Knowledge

Company

ProductLife Group

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ProductLife Group is a trusted partner that helps clients stay ahead of the changing R&D landscape.
dateFounded in 1993
location
Ninove, Oost-Vlaanderen, BEL
people-size501-1,000 employees
web-link
https://productlifegroup.com/

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
Oakley Capital
2024-05-28Private Equity
2019-01-22Acquired

Leadership Team

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Xavier Duburcq
CEO and Chairman
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Recent News

globallegalchronicle.com
ProductLife Group’s Acquisition Of IntiQuan AG
2024-11-01
GlobeNewswire News Room
ProductLife Group (PLG) Acquires Callisto to Strengthen Regulatory Services in the UK and EU
2024-10-30
PharmiWeb.com
ProductLife Group (PLG) Acquires Halloran to Further Expand Its Global Reach and Capabilities to Support the Development of New Therapies
2024-10-18
Company data provided by crunchbase
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