Compliance Analyst
Job description
Job Title: Compliance Analyst
Location : Cambridge MA
Contract : (6 months possible extension)
Pay Range: $45-46/hr
About the Role:
Objectives/Purpose
Ethics & Compliance (E&C) focuses on what the organization needs by partnering closely with the business stakeholders to help create, support and enable an embedded ethics and compliance framework. We do this by * Ensuring that our values are at the core of business conduct and underpin individual behaviors and decisions to effectively manage corporate risks.
- Being a forward-thinking leader who anticipates the impact that changing regulations and public debate on topics of ethics will have on the business.
- Taking a modern approach to the E&C operating model by establishing and maintaining a functional structure and agile framework, supporting the achievement of s Vision 2025 and the E&C strategy. E&C will respond rapidly to changing environment and business needs. It is close to the market, encourages and helps enable ethical in line with s values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage risks. E&C commits to
- Act as role model for ‘s values and foster an ethics and values-based decision-making mindset in internal clients, partners and team.
- Enable the organization to make ethical decisions in line with our priorities of Patient, Trust, Reputation, and Business.
Key Responsibilities
- 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, -organized meetings and events) ethically and in compliance with regulatory requirements and standards.
- Lead E&C initiatives aimed at raising awareness of ‘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.
- Leverage advanced AI tools and other IT solutions to enhance the effectiveness of the R&D E&C Team and E&C program implementation.
Qualifications
- Minimum 5 years of 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 project management skills and able to develop and execute project plans to contribute to successful outcomes.
- Strong analytical, detail-oriented, and problem-solving skills with the ability to think strategically and identify opportunities to enhance the compliance program.
- Strong interpersonal skills to build relationships with stakeholders at all levels.
- Experience in leading cross-functional E&C projects or initiatives.
- Excellent written and verbal communication skills, with the ability to effectively convey complex compliance concepts to diverse audiences.
- Advanced proficiency in AI tools, training course development tools, and wide range of IT solutions.
- Proven ability to work collaboratively and effectively with global cross-functional teams and business owners to achieve compliance objectives.
- Maintains good physical and mental health to handle the demands of the role effectively. * Bachelor’s degree required; an advanced degree is a plus.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian’s platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian’s brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.