CMC Regulatory Affairs Specialist
4 days ago
A leading pharmaceutical company is seeking a highly skilled CMC Regulatory Affairs, Data Entry Contractor to join their team in Foster City, CA. This is a 6-month contract with a possible extension.
Job Summary:
The successful candidate will be responsible for performing data entry using the Company's RIM System to enter relevant information to support key CMC RA stakeholders. They will work collaboratively to support the team by executing routine data entry, such as inputting submission-related dates, and regulatory assessment comments.
Key Responsibilities:
- Perform data entry using the Company's RIM System to ensure completeness, correctness, and consistency of data.
- Work collaboratively to support the team by executing routine data entry tasks.
- Acquire required system skills and knowledge through training supported by manager and peers.
- Work under the general supervision of more senior Regulatory Affairs CMC professionals.
Requirements:
- Familiarity with data entry into complex information systems.
- Experience with Veeva Vaults, with RIM Vault preferred.
- Strong verbal and written communication skills and interpersonal skills.
- Excellent organizational skills and the ability to work on multiple concurrent projects with tight timelines.
- A basic understanding of the role of Regulatory Affairs and regulatory requirements in a limited number of areas.
- Scientific background preferred.
- Biologics experience is a plus.
Preferred Qualifications:
- At least 2-3 years of experience in a related field.
- 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.
About the Role:
This role is a great opportunity for someone passionate about advancing therapeutics against life-threatening diseases while working with a collaborative team in Regulatory Affairs.
What We Offer:
A competitive hourly rate of $66/hour on W2.
How to Apply:
Please submit your application, including your resume and a cover letter, to Sharp Decisions Inc.
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