Documentation Analyst

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

Job Description:

DOCUMENTATION ANALYST (REMOTE) Project 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