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ID: POS08859

Consultant Human Factor Engineering (m/w/d)

Pharma & Biotech
Asap
12 Monate
Remote
Freelance
K-Recruiting Schweiz AG
Ansprechpartner:

Cristina Croppi

+49 89 1890998-625

cristina.croppi@k-recruiting.com

 Consultant Human Factor Engineering (M/F/D)

 

Tasks:

  • We are seeking 3 consultants to support on the scopes below connected to Providing Human Factor Engineering support for drug delivery devices for parenterals

  • BID Scope One

  • Prefilled Syringe (PFS) Needle Safety Devicwe for Self-Admin: Finalization of HFE documentation for submission

  • PFS in Autoinjector (AI): design input documents to finalize/update

  • Pediatric PFS: Design Input and Design Output documentation

  • PFS NSD: completion of US registration dossier

     

  • 2. BID Scope Two

  • Deliverable Due date

  • Update of HFEAS (Human factors application specification) 28.02.2026

  • Update of HFESR (Human factors summary report) for both US and Rest of World submission 28.04.2026

  • Evaluation of DHF documentation as reviewer/approver 30.06.2026

     

  • 3. BID Scope Three

  • Intended Use and Application Sepcification finalization

  • Supervise recruitment feasibility study new indications, including report review

  • Write HFE study waivers

  • Protocol order and protocol update

  • Prepare study samples, supervise recruitment

  • Main field study work overview (remote or onsite)

  • Report review

  • Use related risk analysis update

  • Human factors summary report update

 

Qualification:

  • Very good English language skills

  • Familiar with Novartis systems, i.p. NRV

  • preferred time zone: CET.

     

  • No travel required

 

Requirements: 

Start: 01.01.2026

Duration: 12 months

Capacity: 5 days per week

Location: Remote, client is in Switzerland

Interesse geweckt? Auf gehts!
Ansprechpartner
Cristina Croppi
+49 89 1890998-625
cristina.croppi@k-recruiting.com