Cumberland Pharmaceuticals in Nashville, Tennessee, is recruiting for a position within its Regulatory and Scientific Affairs group. See position details below. To apply, send a cover letter/resume to Sasha Boustani (email@example.com).
||Junior Associate, Document Control
||Senior Director, Regulatory & Scientific Affairs
PART II. - BROAD FUNCTION:
To log, track and maintain the flow of both electronic and hard-copied documents and Clinical & Regulatory department files, for both pre and post marketed products (“Projects’). Assist with regulatory publishing activities.
PART III. - PRINCIPAL RESPONSIBILITIES:
1. Manage the receipt, maintenance, approval, distribution, and storage of documents including nonclinical and clinical trial master files, adverse drug experiences, product complaints, regulatory submissions/correspondence, batch records and standard operating procedures;
2. Maintain accountability for entry of document-related information into applicable logs, both manual and electronic for tracking and accountability purposes;
3. Assure that any data tracking systems are kept current and are operating efficiently;
4. Control electronic templates for regulatory, professional affairs and clinical documents and SOPs;
5. Initiate new SOPs, revise existing SOPs and manage SOP review process as required and as they relate to operations departments;
6. Liaise with Professional Affairs and Regulatory departments to ensure compliance with regulatory reporting/submission deadlines;
7. Other projects or duties, as assigned.
PART IV. - SUPPLEMENTARY INFORMATION:
Required: Must be able to handle several projects simultaneously, be detail oriented and extremely organized. Skilled in the use of word processing, spreadsheet, email, and database software.
Education: Bachelor’s degree preferred.
Preferable: Pharmaceutical industry experience with focus in document control.