ASSISTANT CMC TECHNICAL WRITER NEW BRUNSWICK, NJ 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
ALPHA'S REQUIREMENT #23-00550
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
