Full job descriptionRegulatory 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.