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Remote Regulatory Affairs Assistant II | WFH

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

California (USA), United States

Offer summary

Qualifications:

2-3 years of relevant experience, Bachelor's degree preferred, Proficiency in data entry systems, Experience with Veeva Vault required, Understanding of Regulatory Affairs.

Key responsabilities:

Execute data entry tasks in RIM System
Collaborate on routine data entry functions
Maintain data accuracy and completeness
Gain skills through training and support
Work under mentorship of experts

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2 - 10 Employees

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Job description

Job Overview

We are excited to invite applications for the position of CMC Regulatory Affairs Data Entry Contractor. This role offers a remarkable chance for individuals who are dedicated to contributing to the advancement of therapeutics for life-threatening diseases, while working collaboratively within the Regulatory Affairs domain.

Key Responsibilities

Execute data entry tasks utilizing our Regulatory Information Management (RIM) System to assist key stakeholders in CMC Regulatory Affairs.
Collaborate with team members to perform routine data entry functions, which include the input of submission-related dates and regulatory assessment comments.
Maintain the accuracy, completeness, and consistency of all data entered into the system.
Acquire essential skills and knowledge through comprehensive training and support provided by your manager and colleagues.
Operate under the mentorship of seasoned Regulatory Affairs CMC professionals.

Required Skills

Proficiency in data entry within complex information systems is crucial.
Experience with Veeva Vault is mandatory; familiarity with RIM Vault is an advantage.
Strong verbal and written communication skills, complemented by effective interpersonal abilities.
Exceptional organizational skills and the capability to manage multiple projects simultaneously under tight deadlines.
A foundational understanding of Regulatory Affairs and its requirements across various domains is essential.
A scientific background is preferred, with experience in biologics being a significant plus.

Qualifications

A minimum of 2-3 years of experience in a relevant field is required.
A Bachelor's degree is preferred.

Career Growth Opportunities

This position provides a unique opportunity for candidates keen on data management and entry. If you possess a passion for engaging with complex data systems and have a meticulous eye for detail, we encourage your application. Please be aware that a substantial portion of this role involves data entry tasks, so alignment with these responsibilities is necessary.

We look forward to welcoming candidates who are eager to enhance our data processes and drive initiatives within our innovative environment!

Employment Type: Full-Time