Temat: CONTRACT-FREELANCE-POLAND HOME BASED-

CONTRACT FREELANCE-Poland-HOME-BASED
- Submission Authorization Associate - 1FTE € 40 to € 45 per hour
depending on experience
Working within a highly qualified team you will prepare submissions
packages for the country specific Regulatory Authorities and Ethics
Committees for the region within which you work. You will liaise
with the authorities as appropriate regarding amendments and
questions Relating to start-up activities.

Additional Responsibilities:

Working proactively as part of a project team you will coordinate
all necessary activities required to gain Regulatory & Ethics
Committee approval for clinical studies.
You will be required to collate and prepare all documentation and
study regional dossiers for approval in accordance with the relevant
local legislations. In addition you will complete all amendments and
respond to queries related submission from the Clinical Teams.
Regular contact with the designated personnel from regulators
Authorities & Ethics Committees must be maintained in order to
Monitor progress of the submission in accordance with study start-up
deadlines.
Experience and Qualification

With a University degree in medicine, science, or equivalent, you
will have previous submissions / dossiers experience within clinical
studies for either a CRO or Pharma company. In addition you will
also require:

Knowledge of ICH GCP guidelines and expertise to review and evaluate
medical data
Demonstrate an understanding of regionally specific legislation
surrounding ethics committees and submissions procedures and
practices
Have excellent interpersonal and presentation skills and the ability
that interact at all levels in this client facing role
Bi-Lingual - you must be fluent native speaker with fluent Polish
since all submission documents to sponsors and many authorities must
be compiled in Polish
Ability to Prioritize work, have excellent attention to detail,
Demonstrate a pro-active attitude and have previously worked within
a team.
jacek.korona @ hayspharma.comJacek Korona edytował(a) ten post dnia 26.03.10 o godzinie 11:42

Temat: CONTRACT-FREELANCE-POLAND HOME BASED-

I am interesting in such job.

My cv is onto goldenline accesible

Waiting for an contact I remain with best wishes

A.Kurcok

Temat: CONTRACT-FREELANCE-POLAND HOME BASED-

I am looking for a job as a CRA. I am convinced that I am the right candidate for this job. I appreciate your taking the time to review my CV, which is onto goldenline.
I hope I will fulfill your requirements and be given a chance to work in your company.
Should you have any questions please contact with me.

Best regards,
Joanna Biernacka