Job Posting: Scientist, Senior Director, Regulatory Affairs, Cumberland Pharmaceutical, Nashville, TN
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Position Title: |
Scientist |
Department: |
Operations |
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Reports To: |
Senior Director, Regulatory Affairs |
Date: |
November 2015 |
PART II. – BROAD FUNCTION:
To assist in non-clinical, clinical, and regulatory responsibilities, primarily researching, coordinating and drafting regulatory packages for new product candidates. Researches, writes, and edits nonclinical, clinical, and/or regulatory documents for submission to regulatory agencies (e.g., U.S. Food and Drug Administration) or for publication or presentation. The Senior Scientist will have experience authoring, compiling, reviewing and submitting various industry documents such as but not limited to, INDs, NDAs and clinical protocols. Secondarily, to represent Cumberland in collaborative partnerships across various research projects. This is a non-laboratory position.
PART III. – PRINCIPAL RESPONSIBILITIES:
Research Activities (liaise with Regulatory Affairs):
- Draft and assist with preparation of IND and other submissions to FDA for new and existing product candidates.
- Review, organize and summarize scientific literature search, non-clinical study report and clinical study report results.
- Identify clinical and nonclinical research sites, design study related documents and oversee research activities.
- Perform scientific literature searches.
- Other necessary functions as defined and/or developed for Development & Regulatory Affairs.
PART IV. – SUPPLEMENTARY INFORMATION:
Required: A strong familiarity with:
- Scientific literature and literature search methods.
- Writing regulatory, and scientific documents
- Ability to perform appropriate scientific review of documents
- General regulatory and scientific knowledge of drug development.
Education: PhD in science related area with 2 to 4 years of relevant experience or BS/MS in science with 4 to 8 years of relevant experience.
Inquiries, resumes, etc should be sent to our HR department, attention Sasha Boustani Zamilpa at sboustani@cumberlandpharma.com.