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Freelance Medical Writer
1 month ago
We are seeking an experienced Freelance Regulatory Medical Writer to join our team at Empatico Consulting. This is a unique opportunity to work with a fast-growing biotech company that discovers and develops immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer.
As a Freelance Regulatory Medical Writer, you will provide medical writing expertise for multiple products and projects. Your primary responsibility will be to 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.
The ideal candidate will have extensive medical writing experience within the clinical research field, a demonstrated understanding of the drug development process, and applicable regulatory guidelines. You should also have experience with writing various documents such as Clinical Study Reports, Investigator Brochures, protocols/amendments, safety narratives, Developmental Safety Update Reports, scientific publications, and briefing books.
In this role, you will coordinate quality control reviews of documents and maintain audit trails of changes; provide input on data analysis planning and interpretation. If you have a proven track record of delivering high-quality medical writing services in a timely manner, we encourage you to apply for this exciting opportunity.
