Principal Scientist, Medical Writing

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 similar document management systems, ensuring compliance with applicable regulatory requirements, internal procedures, and templates

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 experience in authoring or coordinating pharmacovigilance and safety-related documents; Experience in authoring clinical or regulatory documents such as protocols, clinical study reports, investigator's brochures, submission documents, or responses to health authority questions; Practical experience with Veeva Vault, preferably Veeva Safety or Veeva RIM, in regulated document authoring, review, approval, and lifecycle workflows; Strong knowledge of applicable ICH guidelines, GCP, global pharmacovigilance requirements, and medical writing standards; Ability to interpret and clearly communicate complex clinical and safety data, with excellent scientific writing skills and strong attention to detail; Strong document-planning skills and the ability to coordinate input from cross-functional and multicultural stakeholders; excellent written and spoken English

Nice to have

Experience working on biosimilar programs