We seek a (copy)writer with skills and experience in the pharmaceutical industry ideally with a background on biopharmaceutical analytics. We are a startup company with a unique value proposal and we serve the early value chain of pharmaceutical development. More specifically, with our service and a specialized product portfolio, we support biotech companies to develop pharmaceutical products faster.
We believe that the pharmaceutical industry has a rather conservative value chain and we see potential for speeding up the development processes during early drug development. In particular, our products will support smaller biotech companies developing biological generic products, so-called 'Biosimilars' faster.
We redefine the early R&D supply chain for biopharma with a new value proposal.
Your background should ideally include knowledge of regulatory aspects of biosimilar product registration with regulatory authorities (EMA and FDA). Therapeutic proteins (TP) undergo a complex manufacturing process that varies depending on environmental conditions. As biosimilar products are ‘copy proteins based on an already registered and licensed TP from the original manufacturer (the so-called Reference medicinal product, RMP)’, the copy protein (the biosimilar TP) has to be compared to the RMP using analytical methods to demonstrate the highly similar nature of the biosimilar product. This ‘biosimilar exercise’ is regulated by EMA (EU) and FDA (USA).
The white paper should discuss various stages of biosimilar development with a particular focus on biosimilars containing therapeutic monoclonal antibody as the active pharmaceutical ingredient (API). The paper should identify (in the BS guideline) and describe methods for early (comparability) and late (authorization) BS development stages during the analytical, thus, non-clinical ‘biosimilar exercise’.
If you feel at home describing these regulatory issues using web research, EMA, FDA, ICH and WHO guidelines, please apply.
We are seeking a (White paper) writer with the following skills:
• Content writing
• B2B writing experience
• Case study writing
• Good knowledge in regulatory aspects of biosimilar registration process with authority bodies (EMA and FDA) is a major plus.
* Knowledge of technical analysis of bioproteins desirable
• General understanding for the pharmaceutical industry, with a focus on biotech
• Track record of technical, regulatory and/or developmental aspects of biotech products
• Knowledge of Good manufacturing practice (GMP) in the pharmaceutical industry is helpful but not required
• Knowledge of FDA or EMA are helpful. Biosimilar guidelines can be downloaded from their web sites.
• Affinity to detailed writing and research would be great.
• 'Easy-to-read' style preferred
+ Detailed scope document will be supplied
+ 3-4 fundamental research papers will be provided
+ links to websites and regulatory institutions will be provided + PDF docs
+ communication channel: Slack preferred (private channel set up already)
+ background (white) paper can be provided for
+ CDA has to be signed in advance before completing Upwork hire process