Regulatory Affairs Assistant - II*

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title: CMC Regulatory Affairs Assistant II... Data Entry

Duration: 6 months (with the potential to extend if the person is highly competent and a good resource for our team).

Location: Foster City, CA Hybrid 2-3 days if possible / 100% Remote

PR: $40/hr - $62/hr on W2

Top 3 Required Skill Sets: Familiarity with data entry into complex information systems; strong verbal and written communication skills; experience with Veeva Vault, including RIM

Top 3 Nice to Have Skill Sets: Basic understanding of Regulatory Affairs; scientific background preferred; biologics experience is a plus

Key Responsibilities
? Perform data entry using the RIM System to enter relevant information to support key CMC RA stakeholders.
? Work collaboratively to support the team by executing routine data entry, such as the input of submission-related dates, and regulatory assessment comments.
? Ensure completeness, correctness and consistency of data.
? Responsible for acquisition of required system skills and knowledge; training supported by manager and peers.
? Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals.

Knowledge & Skills
? Should have familiarity with data entry into complex information systems.
? Should have experience with Veeva Vaults, experience with the RIM Vault preferred.
? Strong verbal and written communication skills and interpersonal skills.
? Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
? Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
? Scientific background preferred.
? Biologics experience is a plus

Required Years of Experience: At least 2 - 3 years of experience

We are seeking candidates for this position who have a strong interest in data management and entry. Please note that a significant portion of this role involves entering and managing data in complex systems. If you are not enthusiastic about data entry tasks, this position may not be the right fit for you. We encourage applicants who are detail-oriented and eager

To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/

Should you have any questions, feel free to call me on (415) 322-5419or send an email on [email protected] Thanks and Regards

Akarsh Yathiraj Senior Recruiter C. (415) 322-5419 D. (415) 322-5419 A. 611 Gateway Blvd, Ste 120

South San Francisco, CA 94080 W. www.leadstackinc.com

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