Junior Associate, Document Control - Operations, Cumberland Pharmaceuticals, Nashville

Kim Petrie
May 14, 2015

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 (sboustani@cumberlandpharma.com). 

 

PART I. 

Position Title:  Junior Associate, Document Control  Department: Operations
Reports To:  Senior Director, Regulatory & Scientific Affairs  Date: May 2015 

 

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.