Principal Scientist, Medical Writing

Scope and responsibilities Author, review, and coordinate medical writing deliverables across the product lifecycle, from clinical development through the post-marketing phase. Prepare and coordinate key clinical and regulatory documents, including clinical trial protocols, protocol amendments, clinical study reports, investigator’s brochures, submission documents, and responses to health authority questions. Author and coordinate pharmacovigilance and safety-related documents, such as aggregate safety reports, risk management documentation, safety sections of regulatory submissions, signal evaluation reports, and other post-marketing safety deliverables. Work cross-functionally with Clinical Development, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other stakeholders to interpret and clearly present clinical and safety data. Manage document plans, timelines, review cycles, and stakeholder input to ensure accurate and timely delivery. Maintain documents and workflows in Veeva Vault or símilar document management systems, ensuring compliance with applicable regulatory requirements, internal procedures, and templates. Job requirements MSc or PhD in Pharmacy, Life Sciences, or a related scientific or medical discipline; alternatively, a PharmD or MD. At least 5 years of relevant medical writing experience within the pharmaceutical, biotechnology, or CRO environment, with a minimum of 3 years of experience supporting pharmacovigilance activities. Demonstrated experie