Let CSC’s experienced staff step in to help you manage all of your regulatory operations tasks.
One of the challenges life sciences companies face in today’s time- and resource-strapped environment is to achieve the right staffing balance for managing the peaks and troughs of product submissions. Rather than potentially overstaffing regulatory affairs and operations, smart companies are turning to trusted partners for help when staff augmentation is needed.
CSC provides professional staff augmentation to help clients perform all of the typical regulatory operations tasks. For example, CSC’s experienced staff can step in to help clients manage submission timelines when clients don’t have sufficient internal resources to perform certain necessary tasks. We can provide short-term contractor coverage to manage a temporary gap. We can also become a long-term resource to handle all publishing activities should a client choose not to employ a full-time person for such tasks.
CSC has the capability to fill the following staff augmentation positions.
- Submission Manager: This position gives overall project direction to the project team and manages an overall submission project plan and timelines according to a client's specifications.
- Senior Publisher: Under the direction of the submission manager, the senior publisher trains employees to know and apply project-specific job rules. The senior publisher resolves issues, tracks project progress and reports on all of it to upper management.
- Publisher: Under the direction of the senior publisher or submission manager, the publisher performs a series of submission tasks, including indexing, bookmarking, creation of table of contents, hypertext linking, study report processing, electronic Common Technical Document processing and database management.