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.
Reports directly to the Manager, Regulatory Operations
No direct reports
Minimum BA/BS or equivalent work experience in life science or closely related field.
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.
Website : http://www.clinicaldynamix.com/
Clinical Dynamix, Inc., established in 1999, specializes in all levels of Clinical Research and Medical Affairs, both permanent and contract, for the Pharmaceutical, Medical Device and BioTech Industries. Clinical Dynamix works nationwide and our clients range from small "start-ups" to mega corporations. Clinical Dynamix works with Sponsor Companies, Clinical Research Organizations and Site Management Organizations. We are very sensitive to the needs of our clients and our candidates and uphold complete confidentiality and professionalism. Clinical Dynamix, Inc. is a Nationally Certified Woman Owned Business: (Women's Business Enterprise National Council). CDX underwent a rigorous scrutiny of its history, financials, contracts and vision in order to be deemed qualified for WBENC certification. This enhances our ability to partner with leading commercial corporations which are committed to sourcing part of their procurement needs from qualified woman-owned businesses.