Regulatory Project Assistant

1 day ago

Remote, India Innovaderm Research Full time

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the the regulatory and scientific project team members (regulatory affairs, eTMF operations, medical writing, pharmacovigilance, and medical monitoring). The RPA properly manages personal timelines and workload distribution between short term and long term deliverables such that all project deadlines are respected.

**This role will be perfect for you if**:

- You want to have an experience in regulatory and scientific affairs;
- You want to work in a collaborative environment;
- You want to have an impact in a fast-growing company.

**RESPONSIBILITIES**
- Prepares investigator study files (compilation of essential documents electronically for ISF build)
- Assists with initiating and maintaining study files (eTMF)
- Reconciles eTMF user access lists against employee list.
- Download approval letters, communications, and approved documents from IRB portal and send for upload to eTMF
- Supports user requests and site creation for IRB portals
- Prepare project documentation for ethics and regulatory submissions
- Prepares and updates regulatory tracker for assigned studies
- Verification, reconciliation, and tracking of vendor invoices for ethics and translation
- Compile and format Clinical Study Reports (CSRs) and appendices as per requirements for electronic submissions (eg, bookmarks, hyperlinks, eCTD).
- Assists with tracking of medical monitoring communications
- Assists with project tracking activities and status reports preparation
- Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project teams

**Requirements**:
**IDEAL PROFILE**

**Education**
- Relevant education in science or clinical research

**Experience**
- At least 1 year of experience working in an administrative support-type of role/clinical research;
- Experience in the biotechnology, pharmaceutical, and/or CRO industry.

**Knowledge and skills**
- Knowledge and competency with PDF editor software
- Knowledge and competency in Word, Excel, and Outlook
- Quick learner.
- Multi-tasking skills;
- Attention to detail and accuracy in work.
- Ability to work in a fast-paced evolving and global environment

Our company:
**OUR COMPANY**

At Innovaderm, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a Regulatory Project Assistant, you will be eligible for the following conditions:

- Flexible work schedule
- Home-based

**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, Canada, Innovaderm continues to grow and expand in North America, Europe and India.

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