4 months ago
To lead the development, implementation, and continuous improvement of an effective compliance program for all business activities within the Medicine & Innovation Unit (IU) functions.
To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new compliance efforts.
To lead business partner efforts in Medicine & IU and to provide assistance and advice on daily operations and ensure appropriate compliance controls, training, and remediation of findings associated with A&M activities for identified business activities.
To work and collaborate effectively with other teams within the Ethics and Compliance department.
You will actively contribute to the discovery, development, and delivery of our products to our patients and customers.
Our global presence provides an opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success.
We realize that our strength and competitive advantage lie with our people.
We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance.
Our competitive compensation and benefits programs reflect a high regard for our employees.
- Develop, implement and manage compliance systems and tools for Medicine & IU
- Assess training needs for business groups, develops training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for the business area
- Lead and provide direction to a team of Compliance professionals providing business partner support within the Medicine & IU functions
- Maintain overall responsibility for advice and consistency across all Medicine & IU functions
- Provide advice and proposed solutions on ethics and compliance matters relating to Medicine & IU and on a wide range of issues impacting those groups
- Recommend and ensure completion of CAPAs resulting from monitoring of key business activities within Medicine & IU
- Provide input into annual auditing plan for business activities, driven by a risk-based analysis and prioritization and in collaboration with applicable department leaders
- Collaborate with personnel responsible for auditing plans to execute the auditing plan
- Analyze auditing results to recommend improvements in compliance or business operations
- Support other activities of Medicine & IU Compliance Department, including risk assessment and strategic planning, training and communication, health care provider interaction initiatives
- Lead and directly manage a staff of dedicated compliance managers and/or professionals
- Create and maintain a performance-based culture with clear accountability and a sense of urgency for achieving results
- Management includes recommending goals, performance evaluations and input into compensation decisions
- Provide lead compliance business partner support for the IU and the Clinical Development Medical Affairs Respiratory department within the Medicine Business unit
- Bachelors’ degree in Business Administration is required
- Strong history of prior compliance experience in a US-based company, including 6-10 years or similar experience with the branded pharmaceutical business and/or related function
- Previous regulatory or pharmaceutical compliance experience preferred
- Strong interpersonal and management skills and experience
- Demonstrated ability to critically analyze and assess business and regulatory information and effectively communicate up, down and across the organization
- 1-3 years of leadership experience and results in orientation
- Proven ability to lead and influence diverse groups
- History of successful performance
Prior experience in the following areas:
- Medical or R&D Compliance (Medical/Research/Development)
- Compliance business partner experience for Clinical Development or Medical Affairs
- Strong project leadership/management experience
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
If you are interested in this or similar roles, please contact Kathleen McGarrell at firstname.lastname@example.org.