Our client is a fast-growing biotech company.
At only six years old they already have a development portfolio of nine products.
Including a partnered product that is in commercial production and that has seen more than 3 billion doses administered worldwide and an IPO behind them.
They discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer.
They conduct research globally and have ambitious plans in the UK and US, where they will continue to grow their teams over the coming months and years.
The Role They are looking for Freelance Regulatory Medical Writer contractors - especially any with Orphan Drug Application, Breakthrough/ Fast Track Applications experience.
Ideally clinical, regs, and CMC experience.
You will provide medical writing expertise for multiple products and projects.
This will include interfacing cross functionally to ensure accurate and timely completion and delivery of information and review of scientific publications or clinical regulatory submissions.
Serving as the scientific writing expert for the company, key stakeholders will be medical, clinical, manufacturing, programme management, research, immunology, regulatory affairs and QA.
As part of the job you will write, or have input into, documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical documents (CTDs) clinical/non-clinical overviews and summaries, safety update/aggregate reports and integrated summaries of safety and efficacy.
You will need to coordinate quality control reviews of documents and maintain audit trails of changes; provide input on data analysis planning and interpretation.
Experience & Qualifications You will have extensive medical writing experience within the clinical research field together with a demonstrated understanding of the drug development process, and applicable regulatory guidelines.
Experience with writing a variety of documents (Clinical Study Reports, Investigator Brochures, protocols/amendments, safety narratives, Developmental Safety Update Reports, scientific publications, briefing books.
Experience in early phase (I-II) studies Excellent working knowledge of ICH GCP and current clinical trial legislation and current medical/ scientific/ manuscript writing guidance.