|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.
- 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.
|Reporting: ||Reports directly to the Manager, Regulatory Operations |
|Managerial: ||No direct reports |
|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.