i-Pharm Consulting

Submission Specialist - The Netherlands

Location
Netherlands
Salary
Negotiable
Posted
30 Nov 2018
Closes
31 Jan 2019
Ref
SSSN7888
Discipline
Regulatory Affairs, CMC
Contract Type
Permanent
SUBMISSIONS SPECIALIST | NETHERLANDS | GLOBAL CRO



Are you looking for a new working environment, with a flexible employer that will boost your progression? A Global CRO are looking for a Submissions Specialist to join their team in the Netherlands. The client have a pipeline of upcoming ground breaking global studies within a range of therapeutic fields. They are currently looking for someone to perform these duties for global trials. The company are offering fantastic opportunities to work reduced hours and to work more hours at home to avoid traffic. Added to this there is a fantastic salary package with this job offer, read on to find out more!



JOB TITLE



Submissions Specialist



LOCATION

Netherlands



SALARY & BENEFITS

Very Competitive Salary package + Benefits

+13th month

+Reimbursement of Mileage/Transportation allowance

+Pension

+Healthcare

+Life insurance

+Meal vouchers

+Phone

+Laptop

+Flexibility to work from home



ROLE/DESCRIPTION



In charge of different regulatory submissions as well as the preparation and review of local ethics.

To work directly with local regulatory authorities. You will also be in charge of negotation of contracts, costumaization

of ICF and more. The would be candidate will be the key person on the country level for the submission and all the

oversight of the projects. Make, review and keep track of contracts using the legal and commercial knowledge.

Additional Tasks would performed according to departmental needs.



REQUIREMENTS

Study activation experience of at least 12 months

Life Sciences Degree or equivalent, in a scientific or healthcare discipline

Vast knowledge of the local requirements for submissions

Experience working in a CRO, Medical Device or Pharma Company

Must speak Dutch and English (flexible for fluency)





ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.



www.i-pharmconsulting.com





TO APPLY:

If you would like to discuss this vacancy further, please call the Benelux Clinical Operations Consultant Mak Ishola on +32 (0)2 808 2151, or email mishola@i-pharmconsulting.com. If this role is not suitable, Mak is also available to discuss other possible positions or answer any general questions regarding your career and the current market.



KEYWORDS

Study Start up Specialist/ Country Approval Specialist / Site Initiation associate / Site Initiation Specialist / Site Start Up Specialist / Initiation Associate / Site Activation Specialist / Initiation Specialist / CRA / CTA / CRAI / CRA II / SSU / Senior CRA / SCRA / Submission Specialist / Senior Research Monitor/ Senior Clinical Trial Monitor / Senior Clinical Site Manager / Senior CSM / CSM / Clinical Site Manager / CRA / CRAI / CRA II / SSU / Senior CRA / SCRA / Senior Clinical Research / Global Trials Submissions Specialist / Global Clinical Trials Submissions Specialist / GCTSS / GCSS / Senior Clinical Research Associate / Lead CRA / LCRA / Monitoring /Monitor / Clinical Trial / Drug Trial / Trial Sites / Clinical / CRA 1 /CRA 2 / Associate / Lead CRA / LCRA / Monitoring /Monitor / Clinical Trial / Drug Trial / Trial Sites / Clinical / CRA 1 /CRA 2 / ICH-GCP / Clinical Research / Clinical Trials / Study Start-Up / Start-Up / Study Start Up / SSU / Clinical Study Start-Up/ ICH-GCP / Clinical Research /Central Europe / Regulatory Affairs / Regulatory Documents / ICH-GCP / Central Europe / Eastern Europe / SCRA / Clinical / Home Based / Office -Based / Amsterdam / Rotterdam / Utrecht / Eindhoven / Den Haag / Nijmegen / Lent / Rotterdam / Arnhem / Breda / Maastricht / Tilburg /Groningen / Holland / Noord Holland /Zuid Holland / Noord Brabant / Nederland

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