POSITION OBJECTIVE: Prepare Word and PDF documents to eCTD standards for submission to global health authorities and support regulatory affairs in document management.
Position could be located in either our Buffalo, New York office or our Cranford, New Jersey office.
Essential Job Functions/Responsibilities
- Ensures document formatting for paper and electronic documents are correct and appropriate and according to standards.
- Maintain publishing and quality control logs.
- Support regulatory affairs team with publishing on all eCTD submissions – including INDs/CTAs, NDAs/MAAs– for US and globally according to requirements.
- Collaborate with regulatory affairs team on necessary updates to SOPs and work instructions.
- Provide regulatory publishing support to other departments as needed.
- Other activities as may be assigned by management.
Required Qualifications & Education
- Bachelor’s degree required
- 2+ years of publishing experience
- Excellent working knowledge of Microsoft Office software, especially Microsoft Word
- High-level proficiency in creating, editing and optimizing portable document format (PDF) files and properties; experience with Adobe Pro
- Strong writing, communication and problem-solving skills
- Well organized with good attention to detail
- Experience working in an SOP-driven environment
- Knowledge of CTD Standards and ICH preferred
- Familiarity with xml structures of metadata preferred
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.