Description
Essential Duties And Job Functions
Multi-task in the processing and preparation of many different types of documentation.
Minimise preparation time and maximise 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.
Utilises systems and tools for electronic document capture, 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, organisational and time management skills and attention to detail.
Ability to communicate technical issues to a non-technical audience.
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.
The ideal candidate will align with Gilead's core values by being accountable for their work, displaying integrity in everything they do, thriving in a team environment, and seeing excellence as the only measure of success.
Please send your CV to (see below) or alternatively please call
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.