JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Consulting
Company Size
Middle 1000 – 5000
Requested Expertise
Market Access / Pricing / Health Economics & Outcomes Research
Profile Required
EU Market Access & Pricing experts in FR, IT, GE and SP.
Medical writers (MA&P dossiers).
Biostat, data managers and RWE experts.
Project Description
We are looking for independent experts able to rapidly support us for the launch of a product in haematology.
We have need of HTA dossier writers who can also attend HTA agency hearings to support country managers. Counters: FR, DE, IT, ES.
We have associated needs as well (MA&P / Biostat / Data Managers / RWE experts).
WARNING : Need is urgent – client is behind schedule. Please apply by August 29th at latest.
1/ Dossier developer 1.
>Must have :
Done both CEPS and HAS dossiers in leadership and collaborated with bio stat
Familiar with AIFA and MiH in Spain either through contribution or co-leadership
Has attended CEPS and HAS meetings
Has experienced CEEPS evaluation and is prepared for HE data fit
French native
>Nice to have :
Read and write Italian – ability for AIFA dossier writing
2/ Dossier developer 2.
>Must have :
Done both GKV and G-BA dossiers in leadership and collaborated with bio stat
Familiar with either AIFA and MiH in Spain either through contribution or co-leadership
Has attended G-BA and GKV meetings
German native
>Nice to have :
Read and write Italian – ability for AIFA dossier writing
> Alternatives for Dossier Developers: US or Canadian medical writer who has done the simple writing task of an HAS, AIFA and MiH Spain dossier.
No alternative for attendance at negotiation meeting – this is important as the dossier developer is the only person who has the full knowledge of data available and requirements! (Typically in big pharma this role is with affiliates, which we don’t have here).
If dossier not written in native language + 10-12 weeks through formal three way translation.
As project is in Europe, all business leads are in Europe and the country experts are in Europe it will be tricky to manage the close interaction between data manager bio stat and dossier developer if one is based in a different time zone, other than UK or Europe. In addition attendance of the HTA meeting and pricing agency meeting is in native language and the dossier developer would have to attend.
3/ Country Expert for negotiation HTA and pricing
>Must have :
Native as per GER, FR, IT and SP
Has lead both: HTA and pricing
For Germany may need a legal background in SGB V
Is committed to accompany dossier development
4/ Biostat
>Must have :
Has done ITC for French and Germany dossiers
IS familiar with German stat requirements
Has done clinical data evaluation and re-calibration for French and Germany dossiers before
>Nice to have :
Has done AIFA dossiers and MiH Spain before
5/ Data manager / RWE
>Must have :
Is very familiar with data and registry accesses for GER, FR IT, SP
Has managed large data and data analysis
Has done HTA dossiers before
Familiar with coding in all markets and data retrieval from coding catalogues
IMPORTANT: when applying please mention which topics you are able to cover and specify a daily rate + expected number of days per deliverable (when applicable).
Project start ASAP.
EU Based – Full remote.
Therapeutic Area
Haematology
Language
French,Spanish,German (only Standard German),Italian,English
Hard Skills
HTA Dossier,Pricing,Statistical programming languages (e.g. R,Statistical Analysis Plan,RWE,Database analysis
Soft Skills
Team Player,Prioritizing,Startegic Thinking skills,Strong influencing skills,Commitment,Decision making,Result oriented,Responsibility
Seniority Level
Experience > 10 years,Experience 5 – 10 years
Starting Date
2025-09-01
Project Duration
9 months plus
FTE / nb of days per week
N/A
Project Location
Flexible, France
Remote Flexibility
Yes
Travel Expected
No
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
contact@pharmatch.co