Nesher Pharmaceuticals (USA) LLC
  • 05-Apr-2018 to 04-Jun-2018 (CST)
  • Regulatory Affairs
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


summary

Overall responsibility for managing compliance activities and department procedures as related to the Drug Enforcement Agency (DEA), Missouri Board of Pharmacy and the Missouri Bureau of Narcotics and Dangerous Drugs. Ensure continued compliance with DEA regulations/requirements in 21 CFR 1300 to End, as well as all applicable state regulations.

 

essential Duties and Responsibilities

    • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to staff members and work groups.
    • Manage day-to-day operations of DEA Compliance.
    • Develop and revise procedures for the control of scheduled drugs to ensure correct documentation, traceability, and accountability.
    • Manage the preparation and submission of periodic reports for the DEA (ARCOS, YERS, etc.).
    • Ensure the preparation and submission of all Quota procurement requests for Commercial and R&D activities, including assistance in preparation of supporting data, as required.
    • Perform investigations of inventory discrepancies and in-transit losses and report findings to the DEA as necessary.
    • Partner with the heads of Security, Quality, Operations and R&D to ensure the Company's systems continually meet current DEA standards and requirements.
    • Work with Zydus Sales and Marketing group to ensure continuous monitoring of suspicious orders of controlled substances based upon established criteria and report findings as necessary to the DEA and Missouri state agencies, as required.
  • Execute DEA Compliance personnel training and development, performance appraisal, motivation, improvement, growth, service, and communication.
  • Provide support to Quality management for identifying and achieving key company, operations, and departmental strategies, tactics, and objectives relating to DEA compliance.

 

  • Prepare department and individual goals that are in line with Company and departmental objectives.
  • Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
  • Maintain an understanding of the overall business needs and objectives, including Sales, Marketing, Manufacturing, etc.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • Perform other related duties as assigned to meet departmental and Company objectives.
  •  

KNOWLEDGE/SKILLS/ABILITIES

  • Demonstrated knowledge of and ability to apply DEA and GMP regulations pertaining to controlled substances to manufacturing, sales/marketing, etc.
  • Strong interpersonal skills to effectively establish and maintain collaborative cross-functional working relationships with all levels throughout the organization and outside business partners.
  • Highly organized with strong management skills to effectively plan and manage multiple priorities, projects, duties and tasks concurrently.
  • Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
  • PC proficiency using Microsoft Office and DEA reporting software (ARCOS, YERS, Quota, etc.).
  • Must have the ability to take initiative and work independently where appropriate.
  • Detail oriented with strong follow-through skills.
  •  

EDUCATION/EXPERIENCE

  • Bachelor's degree in Chemistry, Pharmacy, Microbiology, or related field preferred; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
  • Minimum ten years' experience in the pharmaceutical industry with at least five years in DEA Compliance, or relevant experience in a related field.
  • Minimum two years' managerial experience (i.e., managing supervisors and/or professional-level individual contributors).
  • Five years' experience hosting and leading DEA inspections, including direct experience hosting and leading in the preparation, management, and follow-up relating to FDA inspections.
  • Direct experience hosting and leading MO Board of Pharmacy inspections, or similar state agencies.

 

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  1. Stand, walk, sit, reach, talk, and hear.
  2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

 

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  1. Normal office conditions.
  2. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
  3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
Nesher Pharmaceuticals (USA) LLC
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