Regulatory Affairs Assistant - II* at American Cybersystems, Inc. in San Mateo, California

Job Description:

Innova Solutions has a client that is immediately hiring for Regulatory Affairs Assistant - II

Position type: Fulltime - Contract
Duration: 6 Months (with the potential to extend)
Location: 100% REMOTE

As Regulatory Affairs Assistant - II,you will:

Job Description: • 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 preferred.
• 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 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.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Thank you!
Lailun Sheikh
Phone: 412-763-1477
Lailun.Sheikh@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $55.00-$60.00 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• Named One of America's Best Employers for New Grads by Forbes (2024

• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)

• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)

• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)

• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)

• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)

• AWS Advanced Tier Services Partner with 100+ certifications

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.? If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed.? Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.?? Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. Apply Now