Medical Writer
October 20
Description
• Prilenia Therapeutics is seeking a Principal/Senior Medical Writer to support clinical development. • Responsible for preparing written deliverables that meet clinical and regulatory requirements. • Develop and maintain relationships with cross-functional study teams, ensuring document integrity and compliance. • Participate in the development and review of clinical and regulatory documents for submissions.
Requirements
• BA/BS in a scientific, medical or statistical discipline is required; MA/MS or PhD in a scientific, medical or statistical discipline preferred. • Five years’ experience writing scientific, clinical, regulatory or medical articles, at least two years’ experience in a CRO or pharmaceutical company environment preferred; an understanding of medical terminology and statistical methods; strong computer skills including word processing and presentation software. • More than five years of relevant Medical Writing experience, with a minimum of three years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment. • Experience in preparation of clinical/regulatory documents (e.g., clinical protocols, IBs, CSRs, INDs, NDAs/MAAs) • Medical Writer versus Senior Medical Writer designation will be determined by the experience level of the candidate. • Must be knowledgeable of regulatory reporting guidelines and Good Clinical Practices.
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