* Location Newmarket Road,Fordham, CB75WW,United Kingdom
* Employee Type FT Exempt
As a member of the Document Production Team, you are expected to;
* Have a good knowledge of the appropriate GLP/GCP standards and latest regulatory guidelines.
* Be familiar with, and work in accordance with, SOPs and Study Documents.
* Complete all paperwork in compliance with good record keeping principles; correctly and on time in compliance with GLP/GCP.
* Prepare documents in accordance with requirements. Be able to effectively communicate findings and summaries from study data.
* Make suggestions for how processes can be improved and efficiency maximised.
* Take an interest in your own personal development, seek out training, and look for opportunities to grow.
* Embrace the Resolian values and be respectful to your colleagues.
* Be flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges accordingly.
* Take responsibility for knowing what needs to be done in a day, and doing it promptly.
* Be familiar with, and work to Health and Safety Policy relevant to your role.
* Complete any Mandatory Training appropriate for your role.
Other Specific Responsibilities
Individual
* Act as a go to person for advice and guidance of team members and scientific teams
* Plan and organise your work, while being aware of required timelines. Manage your own time and challenge yourself to identify and champion process improvement opportunities
* Play an active role in supervising junior members of the department in document production
* When the opportunity is available, undertake the role of trainer, including delivery of additional on the job, or role specific training for other members of the department
Team
* Communicate workload to line manager and make sure that day to day workload is manageable. Helps other team members to identify periods of high or low workload, and offer appropriate support, advice and guidance
* Have a good understanding of your team’s workload and the status of active projects. Pick up other tasks when you have any spare time and be flexible to help your team succeed
* Let your team leader know if you feel other members of the team would benefit from additional on the job, or role specific training
* Able to present ideas logically and lead team discussions regarding planning, challenges and process improvement
Supporting Responsibilities
* When required work with the BPI 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
* Set a good example for less experienced Report Writers; acting as a coach, buddy or trainer
Technical
* Prepare documents to an exemplary quality, taking into account any Sponsor specific requirements and applying House Style. This includes any publishing (PDF) requirements.
* Use LIMS systems and other data systems to prepare document text, tables and figures
* Support BPIs if required, to resolve audit findings, for which you are responsible. Contribute to external audits as required
* Make sound scientific recommendations in respect to data interpretation and regulatory compliance, setting a good example
* Draft and send day to day emails and documents for BPI review
* Play a role in teleconferences or meetings with the BPI, such as verbal input, presentation or meeting minutes
* Be willing to contribute to publications and presentations when the opportunity becomes available
* Look for opportunities outside of your core role. Contribute and participate without effecting your day to day responsibilities.
Requirements
* Experience in a regulated environment is beneficial.
* Excellent written and verbal communication skills.
* Proficiency in Microsoft word is required, including but not limited to document formatting, editing and template use
* Ability to successfully manage large amounts of information.
* Good organizational skills to perform tasks in a meticulous manner with close attention to detail.
* Flexible attitude to changing priorities and timelines, responding to these challenges positively.
* Good time management skills and ability to work and deliver to tight deadlines.
* Highly motivated and willing to get involved with new initiatives.
Summary
Experienced Report Writers capable of working with minimal supervision, demonstrating significant technical knowledge and the ability to direct their own work. They are able to effectively communicate their knowledge of the regulations and the technical requirements behind reporting standards through active discussion. Where applicable, confidence in effective external communication with the Sponsor will be expected with input into technical and/or operational discussions. The Report Writer will be actively involved in training and coaching of other staff, and will be expected to act as a role model at all times.
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