Senior Medical Writer (Medical Writing Specialist)

About the role

We are looking for a Senior Medical Writer to lead the creation of high‑quality medical and scientific documents. You will work closely with internal and external stakeholders, ensuring that clinical study reports, protocols, and regulatory submissions are accurate, clear, and compliant.

Key responsibilities

• Author and edit routine documents such as clinical study reports, study protocols, and data summaries.
• Research, write, or edit complex documents including Investigator’s Brochures (IBs), INDs, and MAAs.
• Review drafts prepared by junior writers and provide constructive feedback.
• Mentor junior writers and program managers on document preparation, software tools, and regulatory requirements.
• Ensure all deliverables meet quality standards and regulatory guidelines.
• Develop and share 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 5 years of experience in medical writing, preferably within the pharmaceutical or CRO industry.
• Professional medical‑writing credentials (e.g., AMWA, EMWA, RAC) are advantageous.
• Strong knowledge of global and regional document development guidelines.
• In‑depth expertise in a therapeutic or regulatory area.

Required skills

What we offer

• Opportunity to work on innovative medical projects at the forefront of drug development.
• Collaborative environment with cross‑functional teams.
• Professional development and mentorship opportunities.