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 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.
- Experience working on biosimilar programs is desirable.