Senior Medical Writer

Category: Clinical Development

Location:Søborg, Capital Region of Denmark, DK

• Planning, development, and oversight of regulatory documents, including study protocols, informed consent forms, investigator’s brochures, clinical summaries, paediatric plans, briefing packages, and responses to health agency questions according to business needs.
• Representing Clinical Reporting on cross-functional project teams and providing guidance on regulatory document requirements and optimal data presentation.
• Working collaboratively with other job functions across Development (notably Biostatistics, Pharmacovigilance, Medical & Science, Regulatory Affairs, Clinical Operations, and others), ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation - all in accordance with project timelines.

• A track record of driving your own complex tasks from start to end, navigating many different stakeholders, and are an expert in communicating scientific information.
• The ability to improve processes and to promote the sharing of better practices.
• An expert understanding of clinical development, regulatory processes & requirements, and clinical documents.
• Full proficiency in spoken and written English.