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Posted: Wednesday, September 6, 2017 5:19 AM

Job Description:/h3:
Title : Publisher
Type : Contract ( 12 Months +)
Location: Woodcliff Lake, NJ

Description
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.
Qualifications:
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 and ICH Guidances
Must be able to do multi:task and work well under tight timeliness.
Strong verbal and written communication skills
Company Description:/h3:
VIVOS Professional Services, LLC is a Virginia based Recruiting firm offering solutions in 5 functional areas:
1. IT and Technology
2. Healthcare and Life Sciences
3. Trade / Industrial
4. Government Staffing Solutions
5. Outsourcing Solutions
Headquartered in Northern Virginia, VIVOS is operated by a very seasoned management and recruitment team who have worked with thousands of job seekers and employers since the 1990s. Additionally, the VIVOS international team has brought many industrial Trade and Healthcare workers into the US over the years.
We have built our reputation through results.
vivosps

Source: https://www.tiptopjob.com/jobs/71665588_job.asp?source=backpage


• Location: Manhattan

• Post ID: 131871012 manhattan
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