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Senior RA CMC Technical Writer
We're urgently recruiting for a Senior RA CMC Technical Writer who has experience in the pharmaceutical industry and who has hands-on experience with regulatory framework.
Het bedrijf / The company
Your new company is based in the Amsterdam-area and focuses on making the future of medicine better using gene therapy. By doing so, they help patients with serious unfulfilled medical needs. This means that you will, indirectly, contribute to helping those patients and potentially giving them a better life. On a daily basis you will contribute to this as well. The company is continuously looking for highly motivated and skilled people who are willing to make a difference.
De functie / The role
In your new role as a Regulatory Affairs CMC Senior Technical Writer you will lead and coordinate the writing of regulatory documents. You will build up your own team and train and coach them as well. You will provide the right direction regarding the content of filings such as CMC sections of INDs, Module 3 sections for MAA/BLA submissions, IMPDs and authority scientific advice meeting packages. In addition to this, together with the junior RA CMC you will be responsible for summary documents and environmental risk assessment documentation. You will develop documentation frameworks, and leading review cycles in close collaboration with RA, CMC and GMP functions are part of the job as well.
Het profiel / Your profile
The successful RA CMC candidate will hold a PhD in bio-science (or similar) and has 6+ years of relevant work experience. With a MSc you need 10+ years of experience and with a BSc 15+ years of relevant work experience. It is important to have at least 5 years experience within the pharmaceutical/biotech industry, preferably within ATMPs, biologicals or vaccines, as this is the environment you will be working in. Experience with IND/IMPD filings and other regulatory documents, GMO/ERA and MAA/BLA is a good plus. Last but not least, technical writing experience with big regulatory submissions towards national authorities, EMA and FDA is a big asset as well. Excellent English in both writing and speaking are of great importance for this role.
Het aanbod / The offer
You will work in an international and dynamic environment with attractive benefits packages. The salary depends on education and experience. Your new company has good secondary benefits and career opportunities.
Reactie / Reaction
If you're interested in this role as a Junior RA CMC Technical Writer, click 'apply now' to forward an up-to-date copy of your CV, or call Tessa Stuijt on +31651559565.
Tenslotte ..... / Finally ....
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.