Our client is an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Their core purpose is to improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products. It is their reason for being.
Our client is building a Clinical Operations department in Utrecht, for which recently a Senior Director was hired. Currently Herakles is looking for an experienced Regulatory Writer to join the team in Utrecht.
As a Regulatory Writer, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across our client’s portfolio. You will be responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistency across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.
You bring at least 4 years of medical or scientific writing or editing experience, preferably in the pharmaceutical industry. Basic familiarity of the drug development process, clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical studies, and clinical study data collection and results reporting. Oncology experience highly preferred as is authoring clinical components in regulatory filings (NDA, BLA, MAA).
Our client offers initially a one year employment contract with an attractive salary, a bonus opportunity and stock options.
Interested in this role as Regulatory Writer? Please apply through this website. If you have any questions, please reach out to the person mentioned below.
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