George Higginson is currently searching for a highly experienced Senior Manager of Medical Writing for a clinical-stage Biotech, specialising in Immunology. The Head of Medical Writing will be responsible for providing leadership and strategic direction to the medical writing function, acting as 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: Directly contribute to cross-functional teams to integrate medical writing activities into overall project plans. Lead in the development and preparation of high-quality regulatory documents, including clinical study reports, protocols, investigator brochures, and submission documents (e.g., INDs, NDAs, urgent information requests, etc.). 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 7+ 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. Previous people management experience, having built successful teams. Expert knowledge of global regulatory submission requirements and guidelines. Strong technical writing and editing skills across multiple document types. Ability to commute to our Porto, Portugal, office x2 days per week. How
