Senior Associate Consultant – Regulatory Publisher

Senior Associate Consultant – Regulatory Publisher 

R&D Operations · MedEd Agency

Remote or Greater Philadelphia or Boston Area

Ref# 956

Job Summary

Seeking motivated candidate to join award-winning MedEd agency team of consultants committed to delivering quality results to clients & businesses. Consultants & Managers work with Partners & other team members to help organizations solve issues, create value, maximize growth & improve business performance.

Education, Experience, Training, and Knowledge:

  • Bachelor’s degree preferred
  • 5-8 years of experience in the pharmaceutical industry with a focus in Regulatory Operations
  • 5-8 years of experience publishing, submitting & managing documents & submissions in a document repository
  • Experience assisting in publishing or project managing major (NDA, MAA, etc.) submissions
  • Understanding of drug development documents
  • At least 5 years of experience with publishing
  • At least 3 years of experience with regulatory global registration management information & systems
  • Experience assisting with implementation of regulatory technology such as, Documentum, First Docs, Insight Manager, Insight Publisher, etc. (Preferred)
  • Experience assisting in migration of documents & submissions from one regulatory system technology to another (Preferred)
  • Proficient in Microsoft Suite software including Excel, Word, PowerPoint, Visio

Responsibilities

Candidate will work alongside partners, subject matter experts and industry specialists to ensure that all client deliverables meet customer expectations. Will actively contribute to business transformation, process optimizations & system improvements. Candidate will represent company in addressing clients’ business requirements & needs:

  • Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, & management of approval information
  • Manage regional submissions & support global submissions as Lead Publisher
  • Communicate requirements & issues to be considered to Submission Team, & contribute to achieving realistic timelines
  • Collect necessary information from the Submission Team, & plan all submission management related activities
  • Communicate with clients on submission requirements including eCTD
  • Liaise with agency experts on electronic submission requirement
  • Perform quality checking of documents & regulatory submissions to ensure compliance with submission-ready standards
  • Compile & publish regulatory submissions in accordance with current standards & processes using agreed-upon tools
  • Analyze submissions & track & record life-cycle information in accordance with standards
  • Perform complex searches on submission life-cycle information, as required
  • Keep updated on regulatory authorities requirements on technical/format aspects of submissions worldwide & ensure incorporation into agency standards
  • Participate in or lead special project teams (e.g., skill work, standards).

To Apply: Forward your resume, work samples, and answers to our questions from the link https://www.lhazan.com/qa/ to Falguni Shah at falguni@lhazan.com. Refer to “Senior Associate Consultant – Regulatory Publisher in the header.  Lhazan.com