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Technical Regulatory writer

Employeur : PI

Publish date

28/04/17

Job Description:

pi is the consulting partner of choice to some of the world’s leading life science
companies. Thanks to our consultants’ unique expertise and singular experience, we can
offer our clients strategic support of the highest quality. Our continuing focus on
personal development enables us to redefine accepted best practices and challenge
orthodox thinking. Excellence is our standard.
Are you looking to work on different challenging projects in the life sciences industry?
Apply today and join our growing team of consultants.
Currently to support our continuous growth, we are looking for a Technical RA writer .
You will be accountable for the following tasks
● Writing CMC parts of regulatory variations
● Writing Module 2 of regulatory files derived from completed eCTD Modules 3
● Writing IMPDs as far as CMC information is concerned
● Writing Responses to Questions raised by Regulatory Authorities on CMC matters
● Update of internal tracking system linked to their CMC activities
● Involvement in internal initiatives for improvement of processes/ ways of working

 

Our offer
Our remuneration package includes a highly competitive gross salary and extensive
supplementary benefits. To help you grow further as a professional, we offer you a
personalised training program and different career advancement opportunities.

Contact


Apply today and become part of our growing team of life science experts. Send in your resume and introduction letter at [email protected]

Profil / Qualifications Requises

Your profile
● Scientific University degree
● Experience working with Biologicals (if possible preferred over Pharmaceuticals)
● Preferred experience in writing CMC (technical) parts of regulatory documents
   (registration files or variations) for EU, US and International
● Knowledge of regulatory procedures / systems / guidances
● Knowledge of the EU/US variations policy
● Experience in a research laboratory or in regulatory/drug development/public
   health organization
● Motivation for technical writing
● Working experience and/or understanding of the Validation processes is an asset
● Excellent writing skills and good oral communication in English

Apply

Contact Apply today and become part of our growing team of life science experts. Send in your resume and introduction letter at [email protected]

Apply

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