R&D Compliance Manager II

The Opportunity

We are looking for a R&D Compliance Manager II, working in the Pharmaceuticals & Medical Products industry in Cambridge, Massachusetts, United States.

The R&D Compliance Manager will be a member of the Global R&D Compliance Department and have responsibilities for the following: 

  • 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  
  • Projects: Work on special projects on an as needed basis 

This position will assist 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 
Details

The pay we are offering is 59 per hour. This position may present an opportunity to go permanent.

Our Client

Our client is an award-winning clinical development company.  Improving lives globally with 20+ years experience in clinical research and strategic resourcing.  Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities.  Industry expertise sets you up for success with helpful insights, career coaching, and professional training.  Grow and learn while you put your skills to work.  

Experience Required for Your Success
Skills:
  • Bachelors 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 
What Do You Think?

Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.

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