CMC Regulatory Affairs, Data Entry Contractor

Cube Hub Inc. • Contract • California, United States, US • 1d ago

Job Title: CMC Regulatory Affairs, Data Entry Contractor Position

Contract Duration: 6 months (we would like to start with 6 months, with the potential to extend if the person is highly competent and a good resource for our team)

Location: Remote- If the candidate is in the Foster City, CA area, we would prefer that they are onsite 2-3 days if possible

Specific Job Responsibilities

Perform data entry using client 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, 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 .
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 .
Biologics experience is a plus

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

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

Unique Selling Point of this role: This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.

Required Degree Or Certification B.S. Preferred

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 contribute to our data processes.”