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Documentation Analyst

Company: Alpha Consulting
Location: New Brunswick
Posted on: March 17, 2023

Job Description:


  • The primary role is to support the regulatory activities for pre and post submissions for biologic products as part of the CMC Strategies team.
  • The CMC documentation group is committed to supporting the biologics network with integrity, reliability, active engagement and cross-functional collaboration.
  • Support the logistical process for regulatory submissions including Marketing applications and/or post-approval submissions while interfacing across the Client network.
  • Ensure final document compliance to make certain submission content meets formatting requirements.
  • Schedule and facilitate submission reviews and consensus meetings.
  • Facilitate data verification to ensure accuracy of data following internal SOP.
  • Participate in initiatives to promote standardization of submission process within the organization.
  • Participate on various cross-functional project teams, interact with technical experts, regulatory and other key partners both internal and external to the company as necessary. Required Skills:
    • BS degree required.
    • 2 - 4 years of direct pharmaceutical work experience preferred.
    • Experience with MS Suite--specifically MS Word.
    • Experience with ADOBE.
    • Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems.
    • Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process.
    • Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions.
    • Must possess the ability to support multiple projects.
    • Demonstrate commitment to excellence and bring a high energy level to daily activities as well as periods of high intensity work under tight timelines. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Rose: ALPHA'S REQUIREMENT #23-00486 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Keywords: Alpha Consulting, New Brunswick , Documentation Analyst, Professions , New Brunswick, New Jersey

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