Staffing services voor de Life Sciences industrie

(Sr.) Clinical Regulatory Writer

Medical Utrecht 40 uur W&S #1308

De organisatie

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.

De functie

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.

Het profiel

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).

Het aanbod

Our client offers initially a one year employment contract with an attractive salary, a bonus opportunity and stock options.

Inlichtingen bij

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.

Is this vacancy not suitable for you? Then register with us bij clicking on this link and we will be happy to help you find your dream job!

Meer informatie over deze vacature

Albert Hollemans

Associate Director Business Development