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Regulatory Publishing Specialist Job In Berkeley Heights, New Jersey, Katalyst Healthcares & Life Sc

Published 2022-08-10
Expires 2022-09-10
ID #1121186428
Free
Regulatory Publishing Specialist Job In Berkeley Heights, New Jersey, Katalyst Healthcares & Life Sc
United States, New Jersey, Berkeley Heights,
Published August 10, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Regulatory publishing specialist


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Description

   Roles and Responsibilities:



The Publisher is prepared ready to submit to the FDA and other agencies.



This includes, Publishing (Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (e.g Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, CRFs and eCRF Pre-Meeting packages, Labeling)



Knowledge in building different types of submission.



Peer Reviewing of other group members' documents.



Experience in publishing the documents globally.



Knowledge in preparing Paper submission, scanning documents and Printing Desk copies (Internal or Health Authority).



Taking care of every day to day OPDP, Safety Submissions and publishing Clinical Study Reports.



OPDP - Submitting Promotional Material for marketed products.



Office of Prescription Drug Promotional material (OPDP), which is also called as Division of Drug Marketing, Advertising, and Communications (DDMAC) Submission.



Experience in formatting documents as per Client Standards.



Education and Experience:



Minimum of 3 – 4 years' experience in Regulatory Affairs publishing and reviewing the documents in a pharmaceutical environment, with strong familiarity with regulatory eCTD submission process.



Must be highly proficient in Microsoft office, Adobe Acrobat, ISI writer and ISI Toolbox (with



proven background in bookmarking and Hyperlink, page stamp, masking and watermarks etc,).



Experience in Safety Submissions and publishing Clinical Study Reports.



OPDP - Submitting Promotional Material for marketed products.



Office of Prescription Drug Promotional material (OPDP), which is also called as Division of Drug Marketing, Advertising, and Communications (DDMAC) Submission.



Also experience in publishing documents Like IMPD, PSUR, DSUR using TRS Publisher.



Knowledge of eCTD submission eCTD Validator, eCTD Viewer and Life Cycle Management



Must have 2-3 years' experience in using different applications like viewpoint, Insight Publisher or eCTD Express etc.



Must experience in Document Management Systems (example, Livelink, Documentum)



Knowledge in scanning document.



Knowledge in FDA & ICH Guidance's



Must be able to do multi-task and work well under tight timeliness.



Strong verbal and written communication skills



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    Employer's info

    Katalyst Healthcares & Life Sciences
    Registered on October 7, 2017

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