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Documentation Analyst

Company: Actalent
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. Duties and Responsibilities:

  • Support the logistical process for regulatory submissions including Marketing applications and/or post-approval submissions while interfacing across the BMS 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.Additional Skills & Qualifications:
    • 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.Experience Level:Entry Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, New Brunswick , Documentation Analyst, Professions , New Brunswick, New Jersey

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