Regulatory Affairs Assistant - II
Regulatory Affairs Assistant - II
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Job Description
Foster City CA
Slots: 2
Location: Remote If the candidate is in the Foster City CA area we would prefer that they are onsite 23 days if possible.
Hybrid preferred
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 23 days if possible
Specific Job Responsibilities
Perform data entry using Gilead 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 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
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
Unique Selling Point of this role: This role is a great opportunity for someone who is passionate about advancing therapeutics against lifethreatening 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 detailoriented and eager to contribute to our data processes.
Employment Type
Full Time
