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Senior Document Publisher

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Location
Jersey City, NJ
Hourly
$65.00 - $85.00
Job Type
Contract
Date
Feb 21, 2017
Job ID
2441359
Top Tier Pharmaceutical company in Jersey City, NJ needs a Senior Document Publisher- for aconsulting project (6 months and then up for renewal - can be 1099 or w-2 with benefits including health and PTO
contract renewals up to 4 years- can go perm in future as well
- contributes to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major regulatory submissions for his/her assigned products and/or therapeutic area(s) in collaboration with other departmental representatives. 
 
The Senior Document Publisher is responsible for the scheduling, timelines, follow-up, and preparation of all IND/NDA Annual Reports, Amendments, Briefing Documents and other periodic submissions in support of regulatory filings to regulatory agencies.  Working closely with intra-departmental and cross-functional teams, he/she serves as an internal project manager for the submissions process to ensure that submissions are prepared in a compliant, high-quality fashion and within assigned timelines. The incumbent also oversees the document acquisition process and storage/filing of draft and final documents.  
 
KEY RESPONSIBILITIES:  
  • Prepares (e.g.: compile, organize, assembly, and transcribe) applicable information and data for IND and/or NDA applications, Amendments, Supplements, Safety Reports, Annual Reports, Agency meeting/briefing documents  and general correspondence for all assigned clinical development and/or marketed products for submission to regulatory agencies.
  • Provides guidance and support for organization, formatting, and structure of assigned regulatory submissions (IND, NDA) for assigned products and/or therapeutic area(s).
  • Manages the internal submissions process:
  • Tracks and monitors all submissions in-progress
  • Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions.
  • Acts as contact for collection of required documents from participating departments, and distribution of those documents for review and approval by Regulatory Affairs management.
  • Provides regulatory support to other departments and multi-functional teams to ensure compliance with regulatory requirements for content and format of paper/electronic regulatory submissions and documentation.
  • Ensures the accuracy and completeness of electronic and hard copy regulatory files.  
  • Provides support during interactions with regulatory agencies reviewing submission content. 
  • Coordinates and prepares SPL submissions as required.
  • Contributes to process improvement initiatives across the organization.
  • Assists with other regulatory activities and special projects as required.
RELATIONSHIPS:
Reporting: Reports directly to the Manager, Regulatory Operations
Managerial: No direct reports
Other:
 
 
N/A
QUALIFICATIONS:   
Education:
  • Minimum BA/BS or equivalent work experience in life science or closely related field. 
Professional Experience:
  • Minimum of five (5) years overall experience in the pharmaceutical industry.
  • Minimum of three (3) years direct experience with regulatory submissions.
Knowledge and Skills:
  • Proven project management skills; ability to multi-task, meet deadlines as well as coach colleagues to meet deadlines
  • Working knowledge of computer software, including advanced MS Word features.
  • Experience with publishing tools and electronic document management systems as used within the pharmaceutical industry.  
  • Strong problem solving skills.  Ability to manage tasks with clear objectives/goals, measures, process, progress, and results with attention to detail.
  • Strong interpersonal, communication and influencing skills and ability to collaborate effectively with other groups in a matrix organization.