Sr. Manager, Compliance

Location
San Francisco, California
Posted
Jun 07, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Responsibilities

  • Develop compliance training strategy incorporating key priorities, end user role-based segmentation, and effective methods to implement the training strategy
  • Implement regular, effective education and training programs for all employees
  • Assess training performance by utilizing objective measures including industry benchmarking and end-user competency assessments
  • Create internal training materials that verbalize the company’s commitment to compliance  and address specific areas of potential fraud and abuse; deliver content via live class room and web-based sessions
  • Maintain training records consistent with industry best practices & OIG standards
  • Develop training messages that address key concepts relevant to written standards of conduct and policies, procedures and protocols
  • Develop strategic communications that maintain an effective line of communication between the compliance office and employees; develop company-wide communications related to Compliance Program initiatives and enhancements
  • Participate as needed in the implementation of the audit and monitoring activities including field based ride-alongs, speaker program monitoring and backend analytical activities
  • Support Corrective And Preventative Action (CAPAs) program working with functional management and monitor CAPAs to ensure commitments are met
  • Assist the SVP, CCO in implementing the annual risk assessment process and development of the annual Compliance work plan
  • Respond to questions and queries from the employees regarding compliance matters
  • Update and maintain the Code of Conduct ensuring alignment with industry benchmarks
  • Maintain current knowledge of changes, trends, rules, regulations, and industry guidance impacting pharmaceutical commercial activities; including FDA regulations, OIG guidance, federal and state marketing laws, and the PhRMA Code
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert for Commercial and Development personnel
  • Perform other responsibilities as assigned 

Minimum Requirements

  • Bachelor’s degree in Life Sciences or healthcare related field; advanced degree preferred
  • 4-7 years of experience in the biopharmaceutical industry or in a regulatory risk management advisory role, including compliance training experience
  • Advanced knowledge of learning best practices preferred
  • Strong project management experience with ability to work independently, and interact with personnel at all levels and across all functions
  • Organized and detail-oriented with excellent communication skills
  • Familiarity with web based learning management systems
  • Ex-US compliance exposure preferred
  • Adept with MS Office suite of tools
  • Ability to travel up to 25%

Supervisory Responsibilities

This job has no supervisory responsibilities.

Physical Demands

The physical demands described here are representative of those that must be met by an employee 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 employee is regularly required to talk and hear. The employee is required to frequently operate a personal computer and occasionally move about the facility. The employee must occasionally lift and/or move up to 15 pounds. Occasional travel is required.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.