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Assistant CMC Technical Writer

New Brunswick, NJ

Posted: 03/16/2023 Job Number: 23374796

Job Description

Fully Remote.

Project Description:
  • The Assistant CMC Technical Writer is responsible for preparing CMC elements of regulatory filings under a Technical Writer's guidance and supporting the regulatory activities for Marketing Applications and post-approval submissions.
  • This role requires effective collaboration across technical functions to deliver on timelines for submissions.
  • The candidate is expected to have a thorough understanding of regulatory guidelines.
  • The position routinely interfaces with experts in Manufacturing Sciences and Technology, Operations, Analytical Sciences, Quality, and Regulatory Sciences.
  • The successful candidate will work effectively in cross-functional project teams and also independently to accomplish company goals.
  • Author under supervision CMC elements of regulatory filings.
  • Manage the logistical process for regulatory submissions including Marketing applications and/or post-approval submissions while interfacing across the Client's network.
  • Documents included: BLA, MAA, NDA, Briefing Documents, PAS, CBE-0, CBE-30, Variations, HA Queries etc.
  • Ensure final document compliance to make certain submission content meets formatting requirements.
  • Schedule and facilitate submission reviews and consensus meetings. Manage the finalization of drafts for next phase review.
  • Facilitate data verification to ensure accuracy of data following internal SOP.
  • Participate in initiatives to promote standardization of submission process and/or content within 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.
  • Must possess the ability to support multiple projects.
  • Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
  • Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
  • Work under supervision and collaborate with other teams.
  • Deliver results in line with project and team objectives.

Required Skills:
  • Bachelor's degree or equivalent in relevant discipline with a minimum of 3 - 5 years' relevant experience is required.
  • Master's degree with 1 - 2 year's relevant experience; time spent in advanced degree programs may be considered as equivalent relevant experience is preferred.
  • Excellent time management, organizational, and communication skills are required along with proficient navigation of electronic systems.
  • Must have a working knowledge of regulatory submissions.
  • Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
  • Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.Com


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Rose Minchello

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