Tech. Writer, Athenex, Buffalo

As a Technical Writer, you will provide demonstrated FDA submission writing experience to support RD, Clinical Supply, Product Development and Innovation Projects (in-licensing, partnership projects.). The successful candidate will be a highly motivated individual who will work within a science-focused, collaborative environment.

Essential Job Requirements :

  • Plan, write and deliver submission deliverables for US, EU and rest of world (ROW) registrations for multiple dosage forms. Submissions include but are not limited to IND’s, NDA’s, ANDA’s and DMF’s. Very knowledgeable in the requirements of the eCTD.
  • Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports.
  • Experience in Chemistry, Manufacturing and Controls (CMC) technical writing.
  • Develop and contribute to regulatory strategy for successful product registration.
  • Provide and write answers to questions received from regulatory authorities.
  • Ensure all dossiers are in compliance with appropriate SOPs, guidance, GXP and ICH guidance’s and maintain up to date knowledge.
  • Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions.

Desired Qualifications

  • BS in Chemistry, Engineering or Pharmacy required; MS in Chemistry, Engineering or Pharmacy preferred
  • 2 to 5 years of experience in CMC Regulatory/technical writing
  • Must be knowledgeable in pharmaceutical and analytical product development, process validation, CMC documentation for oral, sterile injectable, IV’s, ointment manufacturing and testing
  • Proven ability to lead or work in a cross-functional team-oriented environment in the bio or pharmaceutical industry
  • Excellent verbal and written communication skills

Please review all application instructions before applying to Athenex.