Job Description Unfortunately, we are unable to offer visa sponsorship for this role. 30-35 hours per week. 4-5 days. Monday - Friday. Purpose of the post: Reporting to the Senior Manager at Eurofins Alba, you will assist in producing clinical research and regulatory submission documents such as protocols, protocol amendments, subject information sheet and informed consent documents, clinical study reports, etc. You will ensure that the company is meeting global regulatory requirements and adhering to guidance documents such as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), while still fulfilling the needs, preferences, and styles of sponsors and/or study teams. Main Duties: Assist in the development, revision and maintenance of clinical study synopsis documents and protocols, clinical study reports, and other technical documents. Responsible for authoring and finalising documentation. Interpret, understand, and contribute to the scientific details of the protocol/technical documentation. Identify and resolve gaps to ensure client satisfaction. Assist in, initiate and manage multiple rounds of document review. Ensure high quality documentation that meets regulatory requirements; proofread and copy-edit content as needed. Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process. Prepare ethical study submissions. Author high quality corporate documentation as assigned. Aid with the development of new services to meet the needs of clients. Nurture, develop and maintain relationships with business stakeholders, including clients, partners, or vendors. Provide specialist advice on the products and/or services of the company. Lead client interactions in support of technical documentation associated with studies. Assist Project Managers in the set-up of study information and communication in relation to Protocol and Report production. Participate in client interactions during study start-up activities and/or during study amendment process. Liaise with 3rd Party Consultants/Subcontractors in the production of 3rd party reports e.g. Statistician, Dermatologist Resolve challenges and build consensus between all cross-functional groups and collaborators in a timely manner. Identify, develop and execute continuous improvement projects associated with study documentation. Aid in the development of Standard Operating Procedures and associated training. Manage ad-hoc process improvement/remediation projects as required.