Regulatory Affairs | InSight Data Verification Specialist | 8 months
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands.
This role is critical to ensure the accuracy of EMEA data in the MA data tracking system. The right candidate should be able to effectively drive decisions and enforce actions in a process which is still developing, to take appropriate EMEA decisions independently, and to escalate when needed.
- Liaise with global and local stake holders to ensure alignment between global and EMEA expectations;
- Provide colleagues with training, guidance and communication on the required verification activities;
- Support multiple sites in verification activities as needed, including performing actual verification where appropriate and possible;
- Liaise with Regulatory Affairs to ensure data verification feedback is assessed;
- Liaise with data entry specialists to ensure data verification output is accurately entered in InSight.
• Understanding of local registration data tracking requirements;
• Knowledge of compliance requirements and advanced process thinking;
• Proven ability to deliver complex projects on time;
• Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
For more than 25 years, Janssen Biologics has been a leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their work has revolutionized the science of immunology. They pioneered monoclonal antibody technology, a cutting-edge approach that launched a new generation of products to treat immune-related diseases. Janssen Biologics is a wholly owned subsidiary of Johnson & Johnson.Role Description
We are looking for a Regulatory Affairs Data Verification Specialist to coordinate and support data verification in the Marketing-Authorisation (MA) data tracking system in InSight.This role is critical to ensure the accuracy of EMEA data in the MA data tracking system. The right candidate should be able to effectively drive decisions and enforce actions in a process which is still developing, to take appropriate EMEA decisions independently, and to escalate when needed.
Responsibilities
- Coordinate verification of baseline data in InSight across EMEA Regulatory Affairs teams;- Liaise with global and local stake holders to ensure alignment between global and EMEA expectations;
- Provide colleagues with training, guidance and communication on the required verification activities;
- Support multiple sites in verification activities as needed, including performing actual verification where appropriate and possible;
- Liaise with Regulatory Affairs to ensure data verification feedback is assessed;
- Liaise with data entry specialists to ensure data verification output is accurately entered in InSight.
Requirements
• Good understanding of CTD Module 3 data;• Understanding of local registration data tracking requirements;
• Knowledge of compliance requirements and advanced process thinking;
• Proven ability to deliver complex projects on time;
• Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
Other information
This project will be for 8 months until the end of 2019, with a small chance of overrunning into 2020.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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