Location: Hopewell, NJ
Name: Ashley Abrams
TECHNICAL WRITER Project Description:
The primary role is to support the regulatory activities for clinical submissions (IND/CTA) for biologic products as part of the CMC Strategies team. The CMC group is committed to supporting the biologics network with integrity, reliability, active engagement, and cross-functional collaboration.
- Support the process for regulatory submissions while interfacing across the Client network.
- Assist in the facilitation of authoring, review, verification, and submission-ready compliance for the finalization of filings.
- Preparation of CMC elements of regulatory filings
- Participation on various cross-functional project teams, interactions with technical teams and global regulatory-CMC staff at different Client sites and other key partners both internal and external to the company are necessary.
- Must possess the ability to support multiple projects and to prioritize work independently.
- 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.
- BS degree or MS degree in scientific field with 0-5 years of pharmaceutical experience. Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems.
- Must demonstrate an understanding of the global CMC regulatory guidelines, practices and applications.
- Proven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication.
- Must have a working knowledge of regulatory submissions for clinical submissions (IND/CTA).
- Ability to successfully collaborate with a diverse group of technical professionals and interpersonal styles is required.
- 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.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Ashley: [Click Here to Email Your Resumé]
ALPHA'S REQUIREMENT #18-00214
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE