Randstad Regulatory in Cambridge, Massachusetts
salary:$55 - $58.41 per hour
date posted:Friday, July 13, 2018
Job Title: R&D Compliance Manager II
- The purpose of this position is to support the R&D Compliance program for the Company's Global R&D organization. The R&D Compliance Manager will be a member of the Global R&D Compliance Department
R&D Compliance Monitoring: carry out office monitoring activities sponsored by the R&D organization using the Global Monitoring Toolkit and assist business groups with understanding and implementing of corrective action plans to address monitoring findings.
Transparency Reporting: Assist with aspects of Global Transparency Reporting (e.g. Sunshine Reporting, EFPIA Reporting) throughout the R&D organization
Training: Ensure compliance-owned training courses are properly assigned to appropriate audience via Company's Learning Management system (CLIX)
Projects: Work on special projects on an as needed basis
This position will assist Company's Global R&D Compliance department with the following:
Conduct compliance monitoring of R&D activities against the established policies, procedures, and best practices using the Global Monitoring Toolkit.
Complete quarterly R&D Compliance Monitoring within the established deadlines.
Help design corrective action plans to remediate monitoring findings and ensure policy and procedure enhancements are properly developed and implemented.
Ensure applicable policies and SOPs are properly assigned to its intended audience in CLIX.
Assist with Global Transparency Reporting as necessary
Work on special projects
Bachelor's Degree required
Minimum four years of general business experience in large companies
Experience in Healthcare Compliance
Experience in auditing or monitoring is preferred
Computer proficiency and an ability to utilize MS Office software (e.g., MS Access, MS Excel, MS PowerPoint) required
Must be a self-starter with commitment to personal self-development and possess a strong ability to navigate and master new systems and processes
Highly developed interpersonal skills required: must take initiative and be proactive, inquisitive, and have a strong track record of problem solving
Must be able to coordinate and execute activities from start to finish and work with minimal supervision
Must be detail oriented, have excellent organizational skills and strong ability to handle multiple projects while successfully meeting deadlines
Effective oral and written communications skills in individual and group settings required, along with proven ability to build strong relationships with key stakeholders and colleagues
Shall demonstrate high ethical standards, unquestionable integrity, discretion and professionalism
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.