Medical Writer

The Medical Writer is responsible for writing clinical research protocols, reports and publications. He/she respects high quality standards as well as company deadlines. He/she builds strong relationships with specialized suppliers in medical writing and investigators. Next to this, he/she will also write case report forms, brochures for researchers and scientific articles.

Principal responsibilties

Responsible for editing of clinical development plans to include scientific background and clinical trial strategy and as such works closely with the drug development team leader
Responsible for writing phase I-IV clinical protocols, review of clinical trial data, generation of study reports and study publications/abstracts/posters
Responsible to translate scientific data into tables, figures, graphs etc.
Responsible for drafting/editing summary section for regulatory submissions (CTD, NDA and similar submissions)
Responsible for compiling investigators brochures
Responsible that documents adhere to ICH, cGCP, cGLP, cGMP, etc. quality standards within the agreed timelines
Serves as liaison between outside writing sources and reviews documents prepared by those outside resources

Job Requirements

Education

Degree in Biomedical/Medical Sciences

Experience

Minimum of 3 years experience in writing and preparation of documents for regulatory submissions (of product information) in the pharmaceutical or biotechnology industry

Other qualifications, skills and abilities

Hands-on mentality and flexibility to thrive in an entrepreneurial and fast-growing environment. - Detailed knowledge of FDA and ICH guidelines and regulations related to the format, content and integrity of documents
Confident, pro-active, team spirit and the ability to work under time pressure
Fluent in English, both oral and written
Working knowledge of MS Office (Word, Excel, Power Point and MS Projects)

Compensation