CMC Regulatory Affairs Associate in US-Remote

  • Title: CMC Regulatory Affairs Associate
  • Code: RCI-15735
  • RequirementID: 121554
  • Location: US-Remote
  • Posted Date: 10/03/2024
  • Duration: 6 Months
  • Salary ($): 60.72 - 61.29 per Hourly
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  Job Description


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

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)
 
 
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 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 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.”


About Rangam:

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.

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