REGULATORY DATA ENTRY COORDINATOR
Middle (2-5 ani)
engleză, franceză, română
ProductLife Group is looking for a REGULATORY DATA ENTRY COORDINATOR in Cluj-Napoca!
ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.
As a result of the deployment of a new project we are seeking for a REGULATORY DATA ENTRY COORDINATOR.
We are looking for someone with excellent organisational and interpersonal skills, with ability to work and interact smoothly within an international team. For this role we are seeking a professional with excellent communication skills in English and French.
- Leading the Data entry team, management of the resource of the Group and ensuring project assignments for the delivery of the activities;
- Providing technical support and technical content;
- Representing the company in forums and conferences where he/she intervenes as an expert on a subject;
- Supervising the Data team, when they are entering data in regulatory systems and ensuring the compliance of information entered;
- Creating records in Regulatory Tracking System;
- Ensuring that the regulatory information regarding approved and marketed products worldwide are available;
- Tracking of regulatory submissions and variations in Regulatory Tracking System;
- Executing processes that are required for regulatory information compliance, including storage;
- Executing QC of data entry;
- Supporting the RA Team in developing tools or processes, which are related to documents or submission management;
- Identification, testing and qualification of system enhancements;
- Reporting any equipment and/or system problems.
- Bachelor’s or higher graduate degree in a science related field;
- Minimum 3-years’ experience in the pharmaceutical industry for publishing / RA activities;
- Good knowledge of regulatory affairs/ regulatory information system management;
- Knowledge of regulatory affairs pharma products;
- Effective oral and written communication skills;
- Good computer skills and the ability to learn appropriate software;
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel;
- Fluent in English (spoken and written) and French for daily contacts with local partners and clients;
- Ability to mentor and coach team members;
- Innovative and problem-solving skills;
- Excellent organisational and interpersonal skills with the ability to work well within a team;
- Ability to work with several different teams, departments and stakeholders within PLG Group;
- Excellent communication, planning & organizational skills;
- Customer oriented (communication – coordination);
- Ability to generate trust in clients and to establish long-term relationships with clients;
- Ability to organize a service, track and measure performance;
- Process orientated with good attention to detail.
- Full training on the job and external courses will be provided;
- Competitive salary package;
- Dynamic environment with opportunities for advancement within the company or the wider group;
- International and growing company;
- Flexible working environment;
- Health insurance;
- Meal tickets.