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CMC Technical Writer
Ref No.: 17-01514
Location: Hopewell, New Jersey
Position Type:Contract
Start Date: 11/02/2017
CMC TECHNICAL WRITER
HOPEWELL, NJ

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.

Required Skills:
  • 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.



Please E-MAIL your resume (attachment to email) with rate and availability to Ashley: ashley@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01514
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE