Job as Manager, Regulatory Records in INC Research
INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.
Post: Manager, Regulatory Records
Job Description
Line manages Regulatory Records staff. Manages the workflow process for paper and electronic document management and prioritizes work. Assigns resources to accommodate ongoing workflow. Leads quality assurance and process improvement efforts. Oversees creation and maintenance of the document/file repository and archival for all study-related paper documents, electronic documents, and other documents requiring document control. Participates in business development presentations as a subject matter expert in processing regulatory records within the Company.
Core Responsibilities
1. Works closely with functional team management to ensure deliverables in accordance with relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs). Trains staff on proper procedures and processes.
2. Prioritizes work for the Regulatory Records team. Assists in resourcing to accommodate on-going workflow
3. Creates and maintains the document repository, scanning, and indexing for all study-related documents. Receives, inventories, routes and maintains applicable project documents (e.g. clinical documents and clinical files as well as project specific regulatory documents, etc.).
4. Responds promptly to each request received for a project document or project file, and insures timely and appropriate delivery, as well as timely and accurate re-filing all project documents and project files. Insures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room.
5. Ensures the security and compliance of all documents related to active and archived projects. Ensures that all project documents are maintained in accordance with relevant SOPs/WIs.
6. Ensures prompt responses to each request received for a project document or project file; ensures timely and appropriate delivery, and timely and accurate re-files all project documents and project files. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room.
7. Upon study closure, prepares subject files, prepares inventories, and assists in reconciling files; ships files to client and or off-site storage.
8. Controls access to the Document Control Room/Trial Master File Room according to applicable SOPs/WIs. Responsible for maintenance of the physical space in the Document Control work area/Trial Master File work area, including setting up project file structure for each project and restricting access to project files.
Candidate Profile
BA/BS degree with courses in the scientific/regulatory field or equivalent related experience. Moderate experience in a clinical and/or medical environment that includes working with regulatory records. Experience managing a staff preferred. Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology. Demonstrated leadership skills. Strong verbal, written, and organizational skills with a team-oriented approach. Proficiency in Microsoft Office Suite and email. Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Additional Information:
Qualification: Bachelors Degree
Industry Type: Pharma/ Biotech/Clinical Research
Job ID: 15057
Location: Gurgaon
End Date: 30th September, 2014
See All B.Pharm Alerts M.Sc Alerts Mumbai Alerts
PharmaTutor Magazine- Latest Issues
See All Other Jobs in our Database