Exciting opportunity within medical writing at an innovative biopharmaceutical company 

Orphazyme is expanding and therefore looking for a Senior Medical Writer to support their medical writing activities and provide medical writing insights to the development projects.

As Senior Medical Writer, you will become part of the Medical Writing team consisting of 3 employees; the Manager of Medical Writing and 2 Senior Medical Writers. You will be responsible for your own projects, e.g. Orphazyme’s project in phase II for Gaucher disease, as well as close collaboration within the Medical Writer team on the upcoming submission tasks.

With direct report to the Manager of Medical Writing.

Your main tasks are:

• Support medical writing activities, e.g. clinical dossier, briefing packages, and late-phase clinical trial reports
• Preparation or oversight of regulatory clinical documents, e.g. clinical trial protocols, investigator’s brochures, responses to authorities, clinical summaries and overviews
• Planning and coordination of activities in a cross-functional setting
• Provide medical writing support to various regulatory and scientific documents
• Review of clinical trial documents, e.g. clinical development plans, statistical analysis plans, protocols, and protocol amendments
• Support to other functional areas on communication best practices
• Manage stakeholders, e.g. close interaction with medical affairs and CMOs

Your qualifications are minimum 3 years of experience as a Medical Writer within the pharmaceutical industry and preferably experience with writing clinical dossiers and briefing packages. Alternatively, you have good knowledge of clinical studies and GCP from another specialized position in the industry.

It is crucial that you can drive, manage and write concise and targeted regulatory, scientific documents in collaboration with many stakeholders. Moreover, you must have good analytical skills and the ability to work with large amounts of information. Finally, you must possess excellent communication and collaborative skills.

You have a Master’s Degree within science including skills within scientific research methods.

You are self-driven and able to take responsibility for your own projects. It is crucial that you are proactive and can work independently. You must work in a structured way with an eye for details.

Furthermore, you must be flexible and open to challenges. It is important that you thrive in a dynamic and entrepreneurial research environment and are passionate about working in a novel therapeutic area.

Orphazyme offers a unique opportunity in a company with an exciting pipeline and a positive and informal environment. Orphazyme is growing rapidly and the rate of change is high and hence the opportunities to contribute and influence are many.

Travelling: Limited.

Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.