The Contractor will work in three phases:
Phase 1 – Document Initiation
• At initiation of a new deliverable, the relevant Therapeutic Area (TA) authoring team will provide the Contractor FTE with all relevant information required to complete the deliverables, including a description of the required activities, names of colleagues who will be providing input, timelines, the names of reviewers and approvers and the final handover customer.
• All documents should be prepared according to submission-ready standards.
• Each document will be prepared according to the project team specified timelines, and such timelines will be clearly communicated to the Contractor FTE.
Phase 2 - Document Development
• After agreement of the document strategy between team and the Contractor FTE, the POC will communicate with the Contractor FTE regularly, or as needed, to discuss progress (the Contractor FTE should not wait for a scheduled meeting in order to resolve issues that prevent progress)
• More urgent jobs may require daily meetings in order to meet project timelines
• The Contractor FTE may coordinate and lead meetings (e.g., regularly scheduled team meetings, immersion meetings to review comments, etc.)
• Documents should be prepared and maintained in Global Document Management System (GDMS) at all times to enable real time review of the current draft.
• The POC will act as facilitator between the Contractor FTE and customer and/or contributor, as needed, to ensure waiting times are minimized
• At the time the draft document is deemed ready for team review, the POC will review an early draft and provide comment and strategic direction as necessary to ensure the document meets needs.
• Following this step, the relevant TA authoring member confirms that the draft is ready for full internal team review and either the relevant TA authoring member, or the Contractor FTE, sends the document for team review as per internal SOP(s).
Phase 3 – Document Completion
• Once comments are received, the Contractor FTE addresses editorial comments and updates the documents.
• Technical comments that enhance accuracy and clarity of the document may also be addressed by the Contractor FTE; however, any comment where interpretation is changed, or where there may be uncertainty on how to address the comment, should be raised to the POC.
• The POC will then discuss these review comments with the Contractor FTE and they will agree how they should be addressed.
• For any review comments not implemented, a reason for not doing so should be communicated to reviewers.
• If deemed necessary, a meeting with reviewers may be held to discuss and resolve comments.
• The Contractor FTE may coordinate and lead meetings (e.g., regularly scheduled team meetings, immersion meetings to review comments, etc.)
• QC will be conducted internally and the Contractor FTE will work with the team to address comments.
• Once any QC findings have been addressed, the Contractor FTE sends the document with corrections highlighted to the PCO for final review.
• If satisfactory, either the POC or the Contractor FTE sends the document for approval and once having achieved this, ensures that the document is final and approved in GDMS.
• Finally, the Contractor FTE notifies the pre-defined handover customer and the POC of completion.
• If relevant, the Contractor FTE will participate in activities to complete an Integrated Quality Control Plan (IQCP), which is included in SOP QMS05; the need for undergoing an IQCP will be communicated at initiation of the process by the POC.
• In addition, the Contractor FTE will support any additional QC requirements as mandated by the relevant SOPs.