Regulatory Publisher Job
Company Name:
Arca24.com
Salary period: Annual
Senior Regulatory Publisher needed for a long-term contract opportunity for Yoh's client located in Woodcliff Lake, NJ.
What You'll Be Doing:
- The Senior Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier 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 (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, 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)
- Experience in formatting documents as per company's standards
What You Need to Bring to the Table:
- Bachelor's degree preferred
- Minimum of five to seven (5-7) years of pharmaceutical industry experience in a regulatory publishing role
- 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.).
- Knowledge of eCTD submission eCTD Validator, eCTD Viewer and Life Cycle Management
- Experience in using different application like viewpoint, Coredossier or eCTDExpress etc
Opportunity is Calling, Apply Now!
Recruiter: Tonya Allen
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.Estimated Salary: $20 to $28 per hour based on qualifications.
Arca24.com
Salary period: Annual
Senior Regulatory Publisher needed for a long-term contract opportunity for Yoh's client located in Woodcliff Lake, NJ.
What You'll Be Doing:
- The Senior Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier 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 (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, 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)
- Experience in formatting documents as per company's standards
What You Need to Bring to the Table:
- Bachelor's degree preferred
- Minimum of five to seven (5-7) years of pharmaceutical industry experience in a regulatory publishing role
- 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.).
- Knowledge of eCTD submission eCTD Validator, eCTD Viewer and Life Cycle Management
- Experience in using different application like viewpoint, Coredossier or eCTDExpress etc
Opportunity is Calling, Apply Now!
Recruiter: Tonya Allen
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.Estimated Salary: $20 to $28 per hour based on qualifications.
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