Job Title: CMC Technical Writer (Senior Associate to Senior Consultant level)
Location: Homebased (UK or Europe)
Salary: £40,000 - £75,000 (DOE) plus package including bonus and car allowance
I am currently recruiting for multiple CMC Technical Writers who will work with a global consultancy division, working client dedicated with one of the worlds leading Pharmaceutical businesses.
In this role you will work across an innovative biologics and vaccines portfolio, responsible for the development and definition of CMC content for fillings throughout the product lifecycle (NDA,IND,IMPD,BLA,MAA)
Candidates from Senior Associate to Senior Consultant level can be considered for this position.
- Develop submission plan and support timey execution of regulatory strategies
- Prepare CMC sections of IND’s, NDA’s ad supportive documents
- Work closely with Global CMC Lead to provide regulatory support for assigned project
- Experience working across an innovative product portfolio, ideally with a biologics and/or vaccines focus
- Thorough understanding of drug development process
- Strong technical CMC writing experience
This role comes with some exciting career development opportunities as well as an attractive package and remote working across the UK and Europe.
If interested please apply with your updated CV, and I will be in touch to discuss further.