JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Consulting
Company Size
Startup < 100
Requested Expertise
Health Economics & Outcomes Research / Market Access / Pricing
Profile Required
Requirements
• Be an independent contractor working through your own limited company or Umbrella Agency.
• 5+ years of HTA experience, preferably with ATMPs, gene therapies, or orphan drugs.
• Proven track record in NICE submissions (HST/STA), EU HTA (e.g., JCA), and economic modelling (Excel/Python proficiency).
• Familiarity with regulatory guidelines (EMA GVP, ATMP follow-up).
• Strong understanding of rare disease unmet needs (e.g., retinal dystrophies).
• Excellent communication skills; ability to work independently in a remote setup.
• Location: UK or EU (for compliance/time zone alignment).
• Desirable: Experience with ILAP/PRIME or joint EMA/MHRA consultations.
Project Description
Our client is a UK-based boutique Regulatory Affairs & Market Access consultancy specialising in supporting international biotech and pharmaceutical companies with European and UK market authorizations. They focus on advanced therapies, orphan drugs, and complex submissions, helping clients navigate EMA and MHRA processes efficiently.
The client is seeking an experienced Health Technology Assessment (HTA) Consultant to provide part-time support (10-20 hours/week, flexible) for preparing EU and UK HTA dossiers for two innovative gene therapy products. This remote contractor position is open to candidates located anywhere in the UK or EU, with an initial 6-12 month contract and potential for extension. Ideal for freelancers with proven expertise in ATMPs and orphan indications.
Key Responsibilities
• Develop and refine HTA dossiers, including cost-utility analyses (QALY-based models, NHS/PSS perspective, 3.5% discount rate).
• Align submissions with NICE HST/STA guidelines and EU Joint Clinical Assessment (JCA) requirements for ATMPs.
• Incorporate clinical data from Phase I/II/III trials into economic models and evidence submissions.
• Support joint scientific consultations (EMA/HTACG, MHRA/NICE) and pre-submission engagements.
• Conduct sensitivity analyses and ensure compliance with transparency standards (e.g., full model code access).
• Collaborate remotely with our regulatory team to integrate HTA strategies into MAA preparations.
What Client Offers
• Flexible, part-time remote work with autonomy.
• Opportunity to contribute to groundbreaking therapies in rare diseases.
• Collaborative environment with access to our regulatory expertise.
Therapeutic Area
Oncology
Language
English
Hard Skills
Soft Skills
Seniority Level
Experience 5 – 10 years,Experience > 10 years
Starting Date
2026-06-01
Project Duration
initial 6-12 month contract and potential for extension
FTE / nb of days per week
3
Project Location
UK (remote OK), United Kingdom
Remote Flexibility
Yes
Travel Expected
Yes
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
contact@pharmatch.co