Randstad Regulatory in Cambridge, Massachusetts

Regulatory

job details:

  • location:Cambridge, MA

  • salary:$55 - $58.41 per hour

  • date posted:Friday, July 13, 2018

  • job type:Contract

  • reference:25792

job description

Regulatory

Job Title: R&D Compliance Manager II

Position Description

  • 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

Position Responsibilities

  • 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

Position Requirements

  • 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

Benefits

  • 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.