Regulatory Affairs Job Vacancy at Innovaderm

Innovaderm Hiring: Join as a Regulatory Documents Assistant

Innovaderm, a leading Contract Research Organization (CRO) specializing in dermatology, is currently hiring for the position of Regulatory Documents Assistant (India). The company values collaboration, innovation, reliability, and responsiveness. At Innovaderm, employees work in a stimulating environment with attractive advancement opportunities.

Job Title: Regulatory Documents Assistant (India)

Company: Innovaderm

Detailed Job Description

As a Regulatory Documents Assistant, you will be responsible for establishing and maintaining the Sponsor electronic or paper Trial Master File (TMF) throughout the life of the trial. Your role includes performing record reviews of essential documents for accuracy and quality according to ICH-GCP. Additionally, you will set up the Investigator’s Study File (ISF) binders.

Role and Responsibilities

• Participate in the development of the TMF structure.
• File or import documents in the TMF.
• Perform record reviews of essential documents in the TMF.
• Assign metadata in the eTMF or maintain trackers for the paper TMF.
• Set up the conduct of eTMF quality reviews.
• Receive and review regulatory documents from investigative sites.
• Assemble and ship the Investigator’s Study File (ISF) to investigative sites.
• Serve as an in-house contact to support Clinical Research Associates (CRAs).
• Run monthly reports to ensure accuracy of files.
• Resolve internal quality control findings or external compliance audit findings.
• Deliver the Trial Master File at study closeout.
• Participate in various administrative tasks as required.

Requirements

• Education: College degree.
• Experience: Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry. Experience in the development and maintenance of the TMF is considered a strong asset.
• Knowledge and Skills: Basic knowledge of clinical trial operations, ICH/GCP Guidelines, and other applicable regulatory requirements. Bilingual in French and English (intermediate). Computer skills including proficiency in the use of Microsoft Word and Excel. Ability to prioritize different assignments. Attention to detail and accuracy in work. Respect established timelines, expectations, priorities, and objectives. Versatile and comfortable in a multitasking environment.

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. Innovaderm only accepts applicants who can legally work in India.

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