Senior Medical Writer – Regulatory Content Strategist

About the role

We are partnering with a leading global pharmaceutical and life‑sciences organisation to hire a Senior Medical Writer – Regulatory Content Strategist on a 12‑month contract. The role will be based in Hertfordshire with hybrid working available and will focus on creating, managing and delivering high‑quality regulatory documentation to support global product development and submissions.

Key responsibilities

• Lead planning, development and maintenance of regulatory documents for global submissions.
• Create scientific and regulatory content that meets internal standards and external regulatory guidelines.
• Collaborate with Regulatory Affairs, Clinical, Safety, Biometrics and other cross‑functional teams.
• Drive content strategy and ensure consistency across submission dossiers.
• Interpret complex scientific data and translate it into clear regulatory documentation.
• Manage document timelines and support submission delivery activities.
• Contribute to process improvements and best practices in regulatory writing and content management.

Required profile

• Significant experience in medical or regulatory writing within the pharmaceutical, biotechnology or life‑sciences industry.
• Proven track record authoring and reviewing regulatory submission documents.
• Strong understanding of global regulatory requirements and submission processes.
• Experience working within cross‑functional drug‑development teams.
• Ability to manage multiple projects and competing deadlines.

Required skills

• Excellent written and verbal communication.
• Strong scientific background with ability to interpret complex clinical and technical information.
• High attention to detail and commitment to quality.
• Stakeholder management and collaboration skills.
• Ability to work independently in a fast‑paced, matrix environment.