Production - Documentation Analyst

Position Title: Documentation Analyst
Location: Remote - Eastern Time
Duration: 6 months

Pay Rate: $ 37.13 - 39.46/hr on W2 (Without Benefits)

This position is REMOTE
Work Schedule: Mon - Fri, Business Hours

Summary:
This role will be responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments. This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time. This candidate is expected to have a good understanding of regulatory guidelines.

Job Description:
Manage document preparation of CMC regulatory submission documents to Client standards and ensure final document compliance to ensure submission content meets formatting requirements.
Manage the logistical process in the authoring system for CMC regulatory submissions.
This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams.
Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure.
Author CMC elements of regulatory filings with supervision.
Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.

Education and Experience Required:
Bachelor s degree in a relevant discipline with a minimum of 4 - 7 years relevant experience. OR a Masters degree with 1-3 years relevant experience.
Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams.
Must possess excellent time management and organizational skills and have the ability to navigate in electronic systems.
Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines.

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)
#INDLS