Principal Medical Writer (Pharma)

TL;DR

Principal Medical Writer (Pharma): Authoring complex clinical and regulatory documentation for top-tier pharmaceutical clients with an accent on high-quality deliverables and regulatory compliance. Focus on managing clinical program documents, coordinating cross-functional resources, and mentoring junior staff to ensure project success.

Location: Must be based in the UK or Ireland. Hybrid work is encouraged for those near office locations.

Company

hirify.global provides expert consulting and operational support across the complete product lifecycle for biotech, med device, and pharmaceutical organizations.

What you will do

• Independently author high-quality clinical, safety, and regulatory documents including protocols, study reports, and submission-level documents.
• Manage clinical program documents and coordinate cross-functional resources to ensure timely delivery.
• Interact directly with clients to manage expectations, lead project meetings, and oversee deliverable timelines.
• Review statistical analysis plans and table shells for accuracy and consistency.
• Supervise, train, and mentor less experienced medical writers.
• Ensure adherence to regulatory standards such as ICH E3, E6(R2), and EU MDR/IVDR.

Requirements

• Must be based in the UK or Ireland.
• Minimum of 7 years of experience in writing clinical or regulatory documents for drugs, biologics, or medical devices.
• Advanced knowledge of clinical research principles and regulatory submission requirements (FDA and other bodies).
• Expert proficiency in MS Word, including tables, graphs, and figures.
• Strong project management and communication skills with familiarity in AMA style.
• Bachelor’s degree or higher in a medical or scientific discipline.

Culture & Benefits

• Commitment to diversity, equity, and inclusion with a focus on authentic self-expression.
• Supportive environment that encourages innovation, collaboration, and entrepreneurial spirit.
• Flexible remote and hybrid working policies.
• Personalized review of all applications by the recruitment team.