Medical Writer

George Higginson is currently searching for a hugely motivated, ambitious and hungry Medical Writer for a clinical-stage Biotech, specialising in Dermatology/Rheumatology. They currently have x2 compounds in Phase 3 clinical trials.

As the Medical Writer, you are an integral part of the Clinical Development team responsible for providing medical writing support to our clinical development programs including preparation, development, review, revision and finalisation of clinical, medical and regulatory documents for submission to external stakeholders and communities.

Main Responsibilities:

• Prepare, edit and review medical, regulatory and clinical documents to support the 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.
• 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 the compliance and consistency
• Work with key functions to develop the in-house style to create a consistent and high quality image across the clients documents.

Requirements:

• Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
• At least 2 years’ experience of medical writing in the field of Clinical Development within the pharmaceutical industry or contract research organisations.
• You MUST be based in Porto, Portugal.
• 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.

How