Description
Essential Duties and Job Functions:
* Multi-task in the processing and preparation of many different types of documentation.
* Minimize preparation time and maximize quality of regulatory documents.
* Trouble shoot document issues by applying existing knowledge to solve new problems.
* Performs routine general formatting, and non-routine document processing activities associated with the preparation of submission-standard regulatory documents for both hard copy and electronic submissions. Be able to identify basic issues and proactively engage appropriate individuals for a resolution.
* Utilizes systems and tools for electronic document generation, manipulation, scanning and QC.
* Assists in the management of publications in the reference. database and generating document bibliographies.
* Assists with the electronic compilation of routine documents and reports.
* Must be able to balance multiple routine tasks simultaneously to achieve goals and satisfy customers. Works under general supervision and follows established procedures.
Knowledge, Experience and Skills
* Relevant experience includes electronic document management systems, global regulatory submissions, or other experience directly related to Regulatory Operations.
* Must have good verbal, written, organizational and time management skills and attention to detail.
* Must have a working knowledge of MS Word (application of heading numberings, styles, hyperlinking, cross reference etc), Word templates, Adobe Acrobat and other standard Office tools.
* Experience in managing shifts in/competing priorities or unforeseen challenges, without compromising quality, attention to detail and timeline deliverables while successfully communicating and working with supervisor, team members and customers.
* Experience in working well independently and in a group environment.
* Demonstrated progressively responsible duties in prior positions.
* Experience working in a fast paced environment with tight timelines, large deliverables a plus.
* Experience in document management and Regulatory publishing is a plus.
* Familiarity with pharmaceutical development and Regulatory global submissions is a plus.