To generate study set up and approve documentation in accordance with Fisher SOP’s, GMP and GCP Guidelines and client requirements.
To generate documentation in accordance with Fisher SOP’s, GMP and GCP Guidelines and client requirements for all maintenance of studies.
To work with the Distribution Client Services Project Managers to assist with defining Client requirements for study set up documentation, and to advise on best practice.
Job Duties and Responsibilities
- To liase, with Distribution Client Services Project Management, QA, QC Despatch, Despatch, DSA, Site 2, and Logistics where appropriate to enable creation of project documentation and to ensure it proceeds in a timely and controlled manner in line with project and process requirements.
- Generation of study set up in GPM and all associated processes and documentation including distribution plan, checklists, proforma invoice templates in conjunction with the information provided by the Client Services Project Managers.
- Creation of study set up where required for despatch of comparators and non study related requests
- Returns set up, along with all relevant documentation.
- Approval of study set up in GPM and all associated processes and documentation including checklists, proforma invoice templates in conjunction with the information provided by the Client Services Project Managers.
- Maintenance of studies within GPM and associated documents including checklists, proforma invoice templates in conjunction with the information provided by the Client Services Project Managers.
- Participate in Job Initiation Meetings in a technical capacity ensuring that the technical challenges of new projects are discussed and resolved at an early stage. Attend Close out meetings to review the success of projects and participate in continuous improvement opportunities where appropriate.
- To manage online operational issues relating to the study set up process and work to resolve issues to ensure that operations continue with minimum disruption.
- Understand and follow all Fisher Standard Operating Procedures relevant to Study set up documentation generation.
- Act as the GPM users for the Client services dept ensuring that GPM issues are investigated and resolved quickly in conjunction with GPM super uses and the IS dept.
- Set up of study files and filing of relevant paperwork in accordance with regulatory and study requirements
- Documentation administration tasks where appropriate to facilitate the documentation process.
- Liase with Scheduling and CAD technicians to generate technical diagrams.
- Participation of cross-functional business process improvement activities as required
- Identify opportunities to improve and revise Fisher Standard Operating Procedures for the purposes of process improvement.
- Obtain a working knowledge of Trackwise to enable investigation reports to be completed. Provide support for service level complaints
- Participate in the training of new staff.
Decision Making / Financial Authority
- Study set up structure and content.
- No financial authority.
- Team Leaders, Project Managers & Project Co-ordinators. In addition regular contact with QA, QC Despatch, Despatch, DSA’s, Logistics, Logistics House
- As required – Customer interactions
- Counterparts at other FCS sites
Education / Qualifications
- GCSE or equivalent in relevant subjects.
- Computer literacy.
- Previous experience of pharmaceutical packaging and/or Regulatory Affairs an advantage.
- Must have and be able to maintain a high attention to detail.
- Must be able to work independently and possess problem solving ability.
- Must be adaptable and be prepared to assist with other duties within the section during busy periods.
- Builds Customer Allegiance
- Embraces PPI
- Focus on Growth
- Job Knowledge
- Interpersonal Skill
- Flexible attitude
- Personal Development
- Problem Solving/Decision Making