Quality Document Writer

Paris  ‐ Onsite
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Keywords

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

Start date
ASAP
Duration
10 months
From
Next Ventures Ltd
Published at
26.02.2014
Project ID:
670619
Contract type
Freelance
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