Medical Writer

Regulatory Scientist (Senior Medical Writer)

Location: Hertfordshire (Hybrid Working Available)

12-month contract role

About the Role

We are working with a leading global organisation in the pharmaceutical and life sciences sector to recruit an experienced Regulatory Content Strategist (Senior Medical Writer) on a contract basis.

This role will focus on the development, management, and delivery of high-quality regulatory documentation to support global product development and submissions. You will collaborate with cross-functional teams, helping to create clear, compliant, and scientifically accurate regulatory content throughout the product lifecycle.

Key Responsibilities

• Lead the planning, development, and maintenance of regulatory documents.
• Create high-quality scientific and regulatory content for global submissions.
• Work closely with Regulatory Affairs, Clinical, Safety, Biometrics, and other cross-functional stakeholders.
• Drive content strategy and ensure consistency across submission documents.
• Interpret complex scientific data and translate it into clear regulatory documentation.
• Ensure documents comply with relevant regulatory guidelines and internal standards.
• Manage document timelines and support submission delivery activities.
• Contribute to process improvements and best practices within regulatory writing and content management.

Person Specification

Essential Experience

• Significant experience in medical writing or regulatory writing within the pharmaceutical, biotechnology, or life sciences industry.
• Proven experience 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.

Skills & Competencies

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

Preferred Qualifications

• Advanced degree in a life science discipline (PhD, MSc, PharmD, MD, or equivalent).
• Experience supporting global regulatory submissions.
• Familiarity with structured content authoring and content management systems.

Apply now if you have a strong background in regulatory medical writing and are looking to contribute to a high-impact global programme.