Regulatory Operations Assistant

Cambridgeshire  ‐ Onsite
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Keywords

Description

Regulatory Operations Assistant - 6 months - Cambridgeshire

This is an exciting opportunity for a Regulatory Operations Assistant on a 6 month contract with a global pharmaceutical company based in Cambridgeshire. This individual will be processing and preparing many different types of documents and utilize systems and tools for electronic document generation, manipulation, scanning and QC. This is a rapidly growing company and an excellent time to join the team. This company is very people orientated and has an extremely friendly working environment.

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.

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.

Start date
ASAP
Duration
6 months
From
Aerotek
Published at
21.02.2013
Project ID:
493173
Contract type
Freelance
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