Medical Writer

Job Purpose

As a 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.

Key responsibilities:

• 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, clinical study reports, and modules for a biologics license application.
• 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.
• 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.
• Assist in the development of templates for core documents that ensure compliance and consistency.

Your profile

Education:

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

Experience:

• 3-5 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.

Work Location:
2 days a week in our brand new Cambridge or Porto office.

Why us?

An exciting job opportunity awaits!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

• Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
• Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
• Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
• Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

Our Core Values:
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:

• We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
• We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
• We unlock value: We aspire to create long-term value for investors and communities.