Regulatory Operations Associate

Description

Specific Responsibilities and Skills:
Must have good verbal, written, organizational and time management skills and attention to detail.
Must be able to balance multiple routine and non-routine tasks simultaneously to achieve goals and satisfy customers.
Works under general direction and may independently determine and develop approaches to non-routine problems.
Requires flexibility to work effectively within an environment that has quickly changing processes, priorities and deadlines.
Must be able to problem solve regarding streamlining non-routine department procedures and processes in relation to technology used for managing and publishing submissions.
The position requires a good understanding of MS Word, Word templates, Adobe Acrobat and standard Office tools.
Must be able to master new technical skills and apply them to projects as the industry, and the company, evolves.
Experience in document management and Regulatory publishing is required.
Some experience in working with electronic document management systems is required.
Some familiarity with pharmaceutical development and Regulatory global submissions is required.

Essential Duties and Job Functions:
As a member of the Regulatory Operations team, performs routine and non-routine submission compilation and publishing activities associated with generating hard copy and electronic submissions.
Prepares a variety of routine and non-routine submissions including utilization of publishing tools for electronic and paper submission generation, scanning, QC, and electronic and paper archival in partnership with Central Records.
May participate in supporting and promoting current non-routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
May with guidance participate in submission planning meetings to become familiar with the submission priorities.
May interface with projects managers, regulatory product managers, and or content authors to discuss routine and non-routine submission preparation and content.

Knowledge, Experience and Skills:
As a member of the Regulatory Operations team, performs routine general formatting, template adherence, ToC generation, version control and non-routine document processing activities associated with the preparation of submission-standard regulatory documents for both hard copy and electronic submissions.
Coordinates the endnote referencing process in terms of managing entries into the endnote database, generating within-document bibliographies and providing individual assistance to document authors.
Obtains cited references and ensures entry into the Reference Repository in submission acceptable format.
Assists with the compilation of routine documents such as clinical study reports and application dossiers.
Ensures final document components are electronically archived according to the departmental practices.
Participates in the development or upgrading of templates as well as guidance documents and SOPs that relate to document standards, content and processes.

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.