Medical Writer

**Your mission**:
As a (Senior) Medical Writer, you are an integral part of MoonLake’s Clinical Development team responsible for providing medical writing support to our clinical development programs including preparation, development, review, revision and finalization of clinical, medical and regulatory documents for submission to external stakeholders and communities.

**Your profile**:
**MAJOR ACCOUNTABILITIES**:

- Prepare, edit and review medical, regulatory and clinical documents to support MoonLake’s development programmes including clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
- Drive and coordinate the development of cross-functional documents to ensure completion to timelines.
- Support cross functional project teams by providing medical writing consultancy on various aspects and provide advice on Medical Writing issues and help to resolve problems
- Research and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
- Develop and support QC processes to ensure quality and accuracy within and between development documents.
- Assist in the development of templates for core documents that ensure the compliance and consistency
- Work with key functions to develop MoonLake’s in-house style to create a consistent and high quality image across MoonLake documents.

**JOB REQUIREMENTS**:
**Education**:

- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.

**Experience**:

- At least 5 years’ experience of medical writing in the field of Clinical Development within the pharmaceutical industry or contract research organisations
- Experience in writing for clinical trials across a range of therapeutic areas and geographies, ideally with immunology/dermatology experience
- Previous experience in medical communications, editing and/or publishing would be advantageous

**Skills/Knowledge/Behavioural Competencies**:

- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
- Knowledge of ICH guidelines and data protection law applicable to medical writing.
- Excellent attention to detail
- Team player able to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
- Good time-management skills, resourcefulness, adaptability, flexibility and an ability to manage simultaneous priorities and adapt to changing timelines.
- An ability to work in a structured, independent manner within dynamic teams and a constructive, service‐oriented approach to challenging situations.
- Excellent command of the English language, both verbal and written communication skills
- Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).Demonstrate keen attention to detail and faultless grammar and spelling