Description
Our client, a multinational pharmaceutical company, is currently looking for a CMC technical writer.
The scientific writer will be involved in regulatory activities related to new and existing pharmaceutical products.
Location: Walloon Brabant
Duration: 6 months
Scope of work:
* Writing CMC parts of regulatory life cycle variations/supplement for all destinations
* Writing Module 2 of regulatory files derived from completed eCTD Modules 3
* Writing Responses to Questions raised by Regulatory Authorities on CMC matters
* Support to transversal Regulatory CMC activities
Requirements:
Education
* University level (Life Sciences background is preferred)
Knowledge
* Experience is writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
* Knowledge of regulatory procedures/systems/guidances
* Good level of spoken and written English
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
* Knowledge of the EU/US variations policy
* Experience in a research laboratory or in regulatory/drug development/public health organization
* Manages own time to meet agreed short-term targets
* Ensures the coherence between contributions/quality of final results
* Team player/ability to work under pressure and time constraints
Experience
* Experience is writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
* Experience in a research laboratory or in regulatory/drug development/public health organization
* Good communication skills - Team spirit
* Good writer in English
Keywords:
CMC, regulatory affairs, regulatory, technical author, technical writer, scientific writer, medical writer, CMC