Medical Writer

Bedrijfsnaam: -
Plaatsingsdatum: 21/04/2019
Standplaats: -


SIRE® 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 Chemicals, Biotechnology and Healthcare organisation, based in Zuid-Holland Netherlands.The CompanyProject scope: The Vaccine program is preparing to file for licensure in Europe and the US. Non Clinical studies provide supportive data for immunogencity and efficacy of the vaccine. Consistency of the reported data is of the utmost importance. The candidate will be involved in QC of Non Clinical study reports. Based on identified actions to be taken, the candidate will perform amendments to the reports.

Role DescriptionThe roles offer the opportunity to work with ground-breaking products and manufacturing technologies, be involved with cutting edge science and develop new quality approaches.

ResponsibilitiesFull review of 12 reports with technical guidance and input from team to clean out inconsistencies and rewriting study report sections to fix them. You will interface directly with both internal and external stakeholders to get the report right. Your focus is on compliance. Your role is to ensure that the final versions adhere to a high standard in terms of completeness, accuracy, and compliance of data provided whilst keeping a close eye on timelines.

Requirements- MSc or PhD in biomedical or chemical field
- Writing experience in industry (must)
- Able to gain alignment on divergent issues, under guidance
- Able to make sound judgments based on quality principles and to provide compliant solutions to problems.
- The job holder should be an independent person and should be able to work constructively and negotiate with various parties throughout the organization
- Knowledge of article 9 could be advantageous
- Knowledge of clinical drug development and regulatory processes and procedures within clinical trials is advantageous but not required
- must be able to organize multiple priorities and projects and work independently within area of responsibility
- Planning & organization - Results oriented - Accuracy - Analytical skills, to be used to resolve complex issues - Communicative - Team player

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :