Senior Medical Writer – Scientific Documentation Specialist

About the role

The Senior Medical Writer leads the creation of high‑quality scientific and regulatory documents, translating complex clinical data into clear, compliant manuscripts for internal and external stakeholders. This position operates within an office environment, following a standard Monday‑to‑Friday schedule.

Key responsibilities

• Author and edit routine documents such as clinical study reports, study protocols, and data summaries.
• Research, write, and edit complex clinical and scientific documents, including Investigator’s Brochures (IBs), INDs, and MAAs.
• Review and provide feedback on drafts prepared by junior writers.
• Mentor junior writers and program managers on document preparation, software tools, regulatory requirements, and therapeutic area knowledge.
• Ensure all deliverables comply with quality processes and regulatory guidelines.
• Develop and implement best‑practice methods for document development.
• Assist with program‑management tasks such as timeline creation, budgeting, forecasting, and contract modifications.
• Represent the department in project launch, review, and team meetings.

Required profile

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum of 5 + years of relevant experience, preferably in the pharmaceutical or CRO industry.
• Formal medical‑writing qualifications (e.g., AMWA, EMWA, RAC) are advantageous.
• Demonstrated expertise in therapeutic areas and regulatory submission processes.

Required skills