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Production - Documentation Analyst at Net2source

Production - Documentation Analyst

Net2source New Brunswick, NJ (Onsite) Full-Time

Job Description

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.

Title: Documentation Analyst
Duration: 06 months
Location: 100% Remote

Pay: $35-40/hr on w2

Job Description:

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.

Additional Job Requirements:
None

Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in-with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out-with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.

Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Awards and Accolades:
• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
• Fastest 50 by NJ Biz (2020, 2019, 2020)
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)

Recommended Skills

  • Adobe
  • Biopharmaceuticals
  • Communication
  • Electronic Systems
  • Filing
  • Hardworking And Dedicated
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