Regulatory Content Strategist – Senior Medical Writer

About the role

We are seeking a Regulatory Data and Content Professional (Senior Medical Writer) to lead data interpretation and medical writing for global regulatory submissions, shaping the future of medicine within a dynamic pharmaceutical environment.

Key responsibilities

• Lead a team of Content Strategists and cross‑functional teams to create and execute content strategies for global regulatory submissions.
• Develop and maintain timelines for document production and review, ensuring alignment with project milestones.
• Review documents for clarity, scientific rigour, and consistency, resolving issues with contributors.
• Participate in functional and cross‑functional teams, driving best practices and continuous improvement.
• Partner with stakeholders to influence technical, business, and healthcare initiatives.
• Stay updated on regulatory, scientific, and medical topics relevant to drug development.

Required profile

• Degree in Life Sciences or equivalent with experience in the pharmaceutical/biotechnology industry.
• Proven experience leading cross‑functional teams and delivering projects independently.
• Familiarity with global drug and device development processes, regulations, and guidelines (GxP, GCP, ICH, ISO, MDR/IVDR).
• Expertise in clinical and safety regulatory documentation throughout the product lifecycle.
• Strong analytical ability to synthesise complex data and concepts.
• Excellent communication and interpersonal skills.
• Fluent in written and spoken English.

Required skills

• Microsoft Office Suite
• G Suite
• Adobe Acrobat
• Veeva Vault

What we offer

• Temporary 12‑month contract (outside IR35) with an hourly rate of £60‑£75.
• Fully remote or hybrid working options.
• Opportunity to contribute to advancing healthcare and improving patient outcomes.