Description
Next Ventures is urgently looking for Quality document writers:
Working in close collaboration with process improvement project teams, the QD Manager/Writer will be responsible for developing QDs that are compliant with Good Clinical Practices (GCP) and applicable regulations from Heath Authorities.
Skills/Experience:
* Bachelor's degree or higher in a relevant scientific/health-related field.
* Minimum of 5-7 years of experience in clinical drug development in the pharmaceutical industry. A background in medical writing, trial management, proposal/contract management, or QA auditing would be considered relevant.
* Ideally, 3-4 years of experience in managing/writing clinical R&D QDs (eg, SOPs WINs, etc.).
* Strong knowledge of international GCP guidelines (eg, ICH) and current regulatory requirements (FDA, EMA) related/applicable to the conduct of clinical trials.
* Excellent written and spoken English, in order to interact effectively in a global environment. Conversational French would be beneficial.
* Strong knowledge and proven experience in documenting business processes. Must have the ability to read, understand, and interpret process maps, flowcharts, and/or diagrams.
* Strong facilitation skills: ability to effectively lead global teams through discussions on complex and potentially controversial topics.
* Ability to anticipate issues and assess downstream impacts. Must proactively implement corrective measures, including possible escalation to management.
* Ability to multi-task and prioritize assignments, managing a wide range of tasks and activities in parallel.
Responsibilities:
* Supervise/oversee development of the QD package and provide direction to junior QD Writers, as required.
* Interact with process improvement project teams to review and provide feedback on process maps and related documentation.
* Develop QDs (including SOPs, WINs, and Supporting Documents - templates, checklists, etc.) based on the information provided by process improvement project teams. QDs will be developed using corporate templates and writing rules (to ensure consistency and harmonization of processes).
* Organize and chair review meetings with process improvement project teams, and revise/update QDs according to meeting discussions and decisions.
* Review QDs for overall consistency, quality, and ensure scope is in-line with process as defined by the process improvement project teams.
* Manage the review and approval of QDs, including follow-up with various business representatives and process owners.
* Regularly track and report on assigned tasks, and escalate any issues as they arise.
* Attend regular QD core team meetings, and provide input into QD strategy discussions.
Get in touch for immediate consideration