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Quality Document (QD) Manager/Writer

Eingestellt von Next Ventures Ltd

Projektbeschreibung

NEXT VENTURES IS URGENTLY LOOKING FOR A SENIOR QD FOR A LONG TERM OPPORTUNITY IN PARIS:

QUALITY DOCUMENT (QD) MANAGER/WRITER

The QD Manager/Writer, working in close collaboration with process improvement project teams, will be responsible for developing QDs which are compliant with those standards required by Regulatory Authorities, Good Clinical Practice (GCP) and other related regulations. 

This will be a Full time position and will be based in the client's offices located ouside Paris (France).

SKILLS/EXPERIENCE

- Strong knowledge of international good clinical practices (ICH) and understanding of current regulatory requirements (FDA, EMEA) related/applicable to the conduct of clinical trials
- Bachelor degree or higher in a relevant scientific/health-related field
- Minimum of 5-7 years of experience in the pharmaceutical industry in clinical drug development.  A background in medical writing, trial management, proposal/contract management, QA auditing would be considered relevant
- Ideally 3-4 years of experience in managing/writing clinical R work proactively and take the initiative to implement corrective measures
- Ability to recognize issues that may require escalation to management level
- Ability to multi-task, handling a wide range of assignments in parallel and dealing with urgent issues as they arise

RESPONSIBILITIES

- Interact with process improvement project teams to review and provide feedback on process maps and related documentation
- Develop Quality Documents (including SOPs, Working Instructions and Supporting Documents - templates, checklists, etc.), based on information provided by process improvement project teams, and using corporate templates and writing rules (to ensure consistency and harmonization of processes)
- Perform peer Quality Control on Quality Documents
- Organize and chair review meetings with process improvement project teams, and revise/update Quality Documents according to decisions made by team
- Manage review and approval workflow for Quality Documents, and follow up with business representatives and process owners
- Regularly track and report assigned activities, and escalate any issues
- Attend regular Quality Document Factory core team meetings, and provide input into Quality Document strategy discussions

Interested? Get on touch for an immediate consideration.

Projektdetails

  • Einsatzort:

    Paris, Frankreich

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Next Ventures Ltd