You will get write, review and translation of documents in English, German and Italian
Project details
The Technical Writing and translations will be in English, German and Italian and will cover all GxP documents such as protocols, reports, WI, batch records, training programs etc. for different product regulations such as ATMPs, Large and Small Molecules, Oral Solid Dose, Vaccines, from research, through pre-clinical to commercialization.
The delivery can be custom made, in days, weeks or months depending on the size of the request, complexity and documents workload.
This can be coupled with KPI or OKR to meet expectations and alignment with business strategy and/or roadmaps.
The delivery can be custom made, in days, weeks or months depending on the size of the request, complexity and documents workload.
This can be coupled with KPI or OKR to meet expectations and alignment with business strategy and/or roadmaps.
Language
English, German, ItalianWhat's included $1,500
These options are included with the project scope.
$1,500
- Delivery Time 15 days
- Number of Revisions 2
- Number of Words per Product 15000
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BH
Ben H.
Mar 10, 2026
Product Manager/Business Analyst - Early-Stage HealthTech SaaS Startup
DP
Dina P.
Sep 26, 2024
Create a roadmap strategy for a charity e-learning portal (medical health)
Excellent hire. Will use again.
About Michele
Freelance Management Consultant
100%
Job Success
Bern, Switzerland - 4:36 am local time
Throughout my career, I have been involved in CAPEX and OPEX projects, working across diverse industries from global corporations to start-ups, including Biotech, Pharma, Food, and CDMOs. My experience spans products such as ATMP, large and small molecules (e.g., API), and vaccines (mRNA, attenuated, and inactive), covering the entire lifecycle from raw materials to DS, DP, and fill-finish.
Recently, I completed an Executive MBA in Healthcare Management and an Applied Data Science course. Currently, I am pursuing a CTO program to position myself for transformative leadership roles in Life Sciences.
Key Strengths:
🌎 Global & Strategic Perspective: Leveraged international experience in five countries to lead cross-cultural teams and navigate complex regulatory landscapes successfully.
💡 Innovation Champion: Spearheaded technology transfers and QMS developments, driving operational efficiencies and quality improvements.
🔄 Change Management: Demonstrated ability to adapt and lead teams through evolving market dynamics and regulatory changes.
Impact Across Various Domains:
Advanced a gene therapy product from pre-clinical stage to phase 1 clinical trials.
Successfully contributed to the submission of a IND application to the US FDA.
Restructured the Technical Unit into work packages and Key Performance Indicators (KPIs).
Managed a portfolio of 8 projects within QA, QC, and digitalization domains.
Indirectly managed a team of up to 21 individuals across Switzerland, Denmark, and Sweden.
Ensured mRNA vaccine QA batch release during the COVID-19 pandemic.
Developed the VI/VA (Visual Inspection/Visual Appearance) method and process.
Established the Quality (QC and QA) department, growing the team from 0 to 9 members.
Developed and implemented Quality Management Systems (QMS), training, EM programs, and 3 stability studies.
Conducted a multi-site stability investigation between Switzerland and Japan, aiming to increase API shelf life and company revenues.
Developed a strategy and roadmap for the digitalization of clinical services in Nigeria.
Created AI/ML algorithms for early and better detection of Plasmodium parasite cell infections.
Steps for completing your project
After purchasing the project, send requirements so Michele can start the project.
Delivery time starts when Michele receives requirements from you.
Michele works on your project following the steps below.
Revisions may occur after the delivery date.
Scope definition and project assessment