Manager Submissions Management

Manager Submissions Management

On a daily basis, the incumbent to this position will receive direction from Submission Managers on submission-related activities. Under the mentorship of the Submission Leads; will be provided an opportunity to develop a broad base of skills in both regulatory and e-submission management; will assist the Submission Managers by playing a key role in planning activities using electronic document management and publishing systems; will also assist in the implementation of the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability. The duties and responsibilities include: providing first line support to Submission Managers around submission planning and tracking, and use of electronic document and publishing technology.Coordinate logistical details associated with generating regulatory submissions, including identification and sourcing of submission content, project and timeline planning, oversight of publication activities, and set up and operation of document management, authoring, and publishing tools; identifying issues that may delay product or project and recommends appropriate action to be taken; engaging in lifecycle management of submissions, and implementation of process change; applying quality control processes to ensure document integrity for electronic document collection, storage, retrieval and archive. Assist in establishing electronic submission capability  focusing primarily on implementing the eCTD. Route documents for review and approval using NexDoc review and approval workflows, respectivelyPrepare and maintain templates, which meet regulatory electronic submission standards. Qualifications include: a minimum of 4 years of experience within the pharmaceutical industry and strong project management and/or submission management experience is required. Preferred qualifications: experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired; 4 years Regulatory Affairs or pharmaceutical experience is required; experience in a Regulatory Submissions organization strongly desired; skilled in using desktop applications and proficiency in computer systems and procedures is preferred; knowledge of document management and electronic publishing systems (Documentum, MS Office applications, Adobe Acrobat, MS Project, SAS Viewer, SAS JMP) is a plus; working knowledge of drug development process is required. Must be detail-oriented and able to function in a multi-tasked environment with time constraints; excellent communication, organizational, and interpersonal skills are required.

Please refer to job code SD5482 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Boston, MA
County:	Suffolk County
ZIP Code:	02108
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856