Job Posting: Research Assistant, Cumberland Pharmaceuticals, Nashville, TN

Kate Stuart
November 13, 2015

CUMBERLAND PHARMACEUTICALS

                                                            Position Description

 

PART I.

 

Position Title:

Research Assistant

Department:

Operations

Reports To:

Senior Director, Regulatory & Scientific Affairs

Date:

November 2015

 

PART II.  -  BROAD FUNCTION:

To conduct and coordinate literature search activities in support of product safety surveillance. Secondarily, log, track and maintain the flow of Clinical and Regulatory Department files. 

 

PART III. - PRINCIPAL RESPONSIBILITIES:

  1. Perform literature searches and reviews for assigned products for pharmacovigilance efforts.
    1. Order reference articles
    2. Summarize literature search results
    3. Prepare MedWatch safety reporting forms, as directed
    4. Liaise with Medical Information and Regulatory Affairs department for safety reporting
  2. 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
  3. Assist with development and formatting of documents
  4. Supporting day-to-day activities of clinical team, as needed

 

 

PART IV.  - SUPPLEMENTARY INFORMATION:

 

Required:  Demonstrated ability to accurately and effectively evaluate and summarize medical/scientific literature.  Good communication and computer (Microsoft) skills necessary.

 

Preferable: Understanding of FDA guidelines is preferred.

 

Education:  Bachelors degree or equivalent undergraduate degree required (scientific or healthcare discipline); masters or PhD preferred.

 

Inquiries, resumes, etc should be sent to our HR department, attention Sasha Boustani Zamilpa at sboustani@cumberlandpharma.com.