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Reference # : 18-08955 Title : Job opening for Technical Writer in Pennington, NJ
Location : Pennington, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 02/26/2018 / 08/25/2018  
Description
Job Title         :           Technical Writer:: 22619-1
Location         :           Pennington, NJ
Duration         :           6+ Months      


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.
 
Duties and Responsibilities:
 
  • 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.
 
Requirements and Education:
 
  • 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.

Interested candidates can send their updated resumes on mayank.sharma1@artechinfo.com and you can also reach me at 973-967-3431.