regulatory in cambridge

posted
job type
contract
salary
US$ 55 per hour
apply now

job details

posted
location
cambridge, massachusetts
job category
Biotechnology & Pharmaceutical
job type
contract
salary
US$ 55 per hour
reference number
25792
apply now

job description

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.