Job Title: R&D Ethics & Compliance Programs & Strategy Lead
Job ID: 25-08358
Location: Cambridge, MA
Duration: 6 Months to begin
Position Type: W2-hourly position
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 behaviours 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 client'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 behaviour in line with client'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 Clients 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.
QUALIFICATIONS
- Bachelor's degree required; an advanced degree is a plus
- 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.
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, 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.
- Leverage advanced AI tools and other IT solutions to enhance the effectiveness of the R&D E&C Team and E&C program implementation.