Posted on
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biot ech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Job Description:
• 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.
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