Senior Manager Medical & regulatory Writing

• Lead scientific contribution to the development of medical, regulatory and clinical documents to support MoonLake’s development programmes. This includes (not limited to) clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
• Lead and manage the medical and regulatory writing team along with use of external writing resources when necessary
• Drive and coordinate the development of cross-functional documents to ensure completion to timelines.
• Research and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
• Work closely with subject matter experts to ensure their writing is of the highest standard of technical accuracy.
• Develop and support QC processes to ensure quality and accuracy within and between development documents.
• Lead the development of templates for core documents that ensure compliance and consistency
• Work with key functions to support the development of MoonLake’s in-house style guide to create a consistent and high-quality image across MoonLake's documents.
• Lead the development of processes, SOPs and other controlled documents, including for Medical and Regulatory writing activities
• Partners with Regulatory Affairs and cross-functional colleagues to understand the clinical development landscape e.g. regulatory requirements, competitor strategies and adapts to changes that may impact MoonLake development programs

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

• Experience of 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

• 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
• Ability to proactively identify risks and develop risk mitigation strategies
• Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
• Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity
• Works proactively using solid communication and influencing skills to effectively execute program goals
• Works effectively in a highly complex and fast-paced environment

• 2 days a week in our brand new Porto Office

MoonLake Immunotherapeutics