Ethics & Compliance Strategy Lead (Mostly Remote)

Cambridge, MA

Hello, 
 
My name is Ana, and I am a Recruiter with The Fountain Group.  We are a national staffing firm and are currently seeking a­­­­­­­­ Ethics & Compliance Strategy Lead for a prominent client of ours.  This position is located in ­­ Cambridge, MA (MOSTLY REMOTE). Details for the position are as follows: 
 
Contract role of 7 months, possible extensions. Pay range is $33-45/hr.
Hybrid: MOSTLY REMOTE, minimum 8 days onsite/month. 
 
Job Description: 
  • Lead implementation of compliance risk assessments in collaboration with team members and R&D business functions. Coordinate with business owners to identify effective risk mitigation plans according to the results.
  • Develop compliance monitoring plan and protocols for R&D activities. Lead implementation of monitoring plan. Coordinate with R&D business owners to develop and implement effective remediation plans for any compliance findings. 
  • Drive development and implementation of customized E&C trainings and communications for the R&D organization, ensuring the information are relevant, engaging, and effective in promoting ethical behavior and compliance.
  • Review and approve activity requests to ensure R&D functions conduct activities (e.g., HCP engagements, Takeda-organized meetings and events) ethically and in compliance with regulatory requirements and Takeda standards. 
  • Lead E&C initiatives aimed at raising awareness of Takeda's values and promoting ethical decision-making across the organization.
  • Collaborate with global and R&D stakeholders to ensure high quality data is collected in the new HCP engagement system that can be monitored in the new Monitoring system and enables effective monitoring of R&D activities.
  • Develop and enhance E&C materials and tools designed to support ethical and compliant activities within the R&D organization.
Qualifications:
  • Strong experience in Ethics & Compliance in a pharmaceutical or medical device company.
  • Extensive experience in implementing compliance monitoring, compliance risk assessments, training development and implementation, and SOP development and implementation.
  • Strong understanding of US and global laws, regulations, and industry codes.
  • Strong analytical, detail-oriented, and problem-solving skills with the ability to think strategically and identify opportunities to enhance the compliance program.
  • Bachelor’s degree required.

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