Report Writer

We are seeking a highly organised and detail-oriented Report Writer to support the preparation of high-quality scientific and regulatory documents. Working within a collaborative team environment, you will ensure documents are produced to the highest standards of quality and compliance, while contributing to continuous improvement initiatives and supporting colleagues to achieve team objectives. This role requires strong communication skills, excellent attention to detail, and the ability to manage changing priorities in a fast-paced environment.

As a Report Writer, you are expected to;

• Maintain a strong working knowledge of relevant GLP/GCP standards, regulatory guidelines, SOPs, and study documentation.
• Ensure all documentation and records are completed accurately, compliantly, and in compliance with GLP/GCP.
• Prepare documents in accordance with requirements. Be able to effectively communicate findings and summaries from study data.
• Use LIMS and other data systems to create and maintain document text, tables, figures, and reports.
• Apply sponsor-specific requirements, company house style, and publishing standards, including PDF production requirements.
• Demonstrate flexibility and initiative when managing changing priorities, ensuring deadlines and commitments are met.
• Identify opportunities to improve processes, enhance efficiency, and contribute to continuous improvement activities.

Other responsibilities:

• Proactively manage and communicate your workload, maintaining awareness of team priorities and project status.
• Provide support, guidance, and knowledge sharing to colleagues, helping the team deliver its objectives.
• Contribute to team discussions, planning activities, problem-solving initiatives, and process improvement projects.
• Identify development opportunities for colleagues and support training, coaching, mentoring, or buddying activities where appropriate.
• Work with the BPI (Bioanalytical Principal Investigator) as required, to troubleshoot issues before they impact on the delivery of the document
• Alert BPI to issues, problems, potential amendments or deviations. Work to solve and document issues without delay, and with minimal input
• Maintain an awareness of the customer’s needs; plan ahead to help make sure that deadlines are met
• Support BPIs as required, to resolve audit findings, for which you are responsible. Contribute to external audits as required.
• Make sound scientific recommendations regarding data interpretation and regulatory compliance.
• Play a role in teleconferences or meetings with the BPI, such as verbal input, presentation or meeting minutes

Skills and experience

• Experience in a regulated environment is desirable.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Word, including document formatting, editing, and template management.
• Strong organisational skills, with excellent attention to detail and the ability to manage large volumes of information.
• Effective time management skills, with the ability to prioritise workloads and meet deadlines.
• Adaptable and responsive to changing priorities.
• Self-motivated, proactive, and committed to continuous improvement.