Senior Regulatory Writer
Role Purpose
Deliver high-quality regulatory documentation that meets or exceeds client expectations, ensuring accuracy, clarity, and timeliness while remaining within budget. Contribute value to clients, colleagues, and the broader business, while demonstrating initiative, continuous learning, and a proactive, solutions-oriented approach.
Core Responsibilities
Regulatory Writing, Briefing & Review
- Lead the development of clear, concise, and scientifically accurate regulatory documentation, ensuring appropriate interpretation of data.
- Manage assigned projects and provide guidance to team members on technical and project-related matters.
- Critically evaluate clinical data and client-provided materials to support document development.
- Apply strong knowledge of regulatory authority requirements to inform document strategy and provide guidance to clients and internal teams.
- Ensure adherence to standard operating procedures (SOPs), including proper management and filing of project documentation.
- Identify gaps or inconsistencies in data, documentation, or project execution, and take appropriate corrective action.
- Conduct thorough data checks and quality reviews of documentation produced by others.
- Provide clear and structured briefs to team members, including timelines, scope, and deliverables.
- Review documents for compliance, accuracy, readability, and fitness for purpose.
- Effectively manage workload and proactively address risks or competing priorities.
- Participate in training initiatives and contribute feedback to support continuous improvement.
Team Collaboration & Development
- Collaborate closely with colleagues to ensure consistency, quality, and best practices across projects.
- Communicate effectively with internal teams and client stakeholders.
- Identify tasks suitable for delegation to junior team members.
- Support and coach less experienced writers in collaboration with line management.
- Escalate potential issues or risks in a timely manner.
- Foster a collaborative and supportive team environment.
Client Engagement
- Build strong client relationships as a knowledgeable and reliable point of contact.
- Contribute to discussions to identify challenges and recommend practical solutions.
- Lead client meetings (virtual and in-person) with confidence and professionalism.
Commercial & Financial Management
- Monitor project costs against budgets and support scope adjustments where required.
- Contribute to discussions on changes to project scope or specifications.
- Maintain awareness of financial performance and support efficient project delivery.
- Complete timesheets accurately and meet productivity expectations.
Business Development
- Support business development by contributing to new and existing client relationships.
- Assist in identifying and developing opportunities for additional work with current clients.
Additional Responsibilities
- Promote and uphold organizational values and a positive working culture.
- Undertake additional duties as reasonably required.