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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Documentation Analyst

Job Description

Location: New Brunswick, NJ
Type: Contract
Job #75395

Our client, a leading pharmaceutical company, is hiring a Documentation Analyst consultant on a contract basis.

Work Location
New Brunswick, NJ/Remote

Summary:
Documentation Analyst
This position is REMOTE
Based out of New Brunswick NJ

The primary role is to support the regulatory activities for pre and post submissions for biologic products as part of the CMC Strategies team. The CMC documentation group is committed to supporting the biologics network with integrity, reliability, active engagement and cross-functional collaboration.

Duties and Responsibilities:
Support the logistical process for regulatory submissions including Marketing applications and/or post-approval submissions while interfacing across the client network.
Ensure final document compliance to make certain submission content meets formatting requirements.
Schedule and facilitate submission reviews and consensus meetings.
Facilitate data verification to ensure accuracy of data following internal SOP.
Participate in initiatives to promote standardization of submission process within the 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.

Requirements:
BS degree required.
2 – 4 years of direct pharmaceutical work experience preferred
Experience with MS Suite–specifically MS Word
Experience with ADOBE
Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems.
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.
Must possess the ability to support multiple projects.
Demonstrate commitment to excellence and bring a high energy level to daily activities as well as periods of high intensity work under tight timelines.

Pay Range: $40-41

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