Reports to: Head of Compliance
Location: New England Area
Email: resume@bpsearches.com
Position Summary
The person in this position will develop and direct our ethics and compliance program covering Medical Affairs, Research and Development activities and will serve on the Global Compliance Leadership team, helping to develop and implement our global ethics and compliance strategy. Specifically, this role will have responsibility for:
- Developing, implementing and managing all compliance programs, processes and systems covering research, development and medical activities, with an emphasis on Medical Affairs. Serving as a business partner for these functions and employees, providing business, ethics and compliance advice and training to enhance business operations.
- Identify compliance risks across Global Medical Affairs and establish a sustainable mechanism to mitigate the risks and ensure compliance across organization. Drive compliance related projects for Global Medical Affairs and the broader R&D organization.
- Supporting/conducting compliance investigations and audits. Developing appropriate responses to monitoring, investigations and audits, including remedial measures. Responding to helpline inquiries. Ensure appropriate compliance training for clients. Collaborating across departments to enhance, from an ethics and compliance perspective, business operations.
- Analyzing internal and external ethics and compliance developments and implementing responses to these developments which enhance the global ethics and compliance program.
- Serving as a member of the Compliance Senior Leadership team to continuously improve and enhance the global ethics and compliance program.
- Lead and manage other compliance professionals.
Principal Responsibilities
- Develop and maintain knowledge and understanding of: our organization and its global business operations and strategy; industry laws, regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), Sunshine Act, Company policies, procedures, and guidelines; external legal, regulatory and business developments. Specific knowledge and experience working on Medical Affairs compliance issues required.
- Develop, implement and manage all compliance elements covering research, development and medical activities, with a focus on global medical affairs. Work with other departments and businesses to ensure implementation of appropriate policies, training and other compliance controls.
- Prepare regular reports of findings from the various compliance systems; present such reports and training on other developments to business audiences, including senior leaders.
- Establish and implement new systems and processes to monitor and audit activities and further the compliance monitoring and auditing programs.
- Monitor the external environment to ensure the implementation of external best practices as well as to respond to future business, ethics and compliance developments.
Qualifications
- 15+ years of experience serving in a compliance, legal, regulatory or related role, with a majority of that experience in the pharmaceutical/medical device industries. Experience working on medical affairs compliance issues required.
- Thorough functional knowledge of the elements of a pharmaceutical ethics and compliance program. Must possess thorough knowledge and understanding of the pharmaceutical industry and its business operations.
- Experience leading and managing a team of professionals; demonstrated experience in identifying, developing and leading talent
- Demonstrated project management skills; experience leading cross-functional teams.
- Strong business partner with a focus on collaboration and delivering results.
- Excellent written and verbal communication skills and organization skills. Fluent English, second language preferred.
- In-depth knowledge and understanding of pharmaceutical industry laws, regulations and guidelines, including privacy and protection, anti-corruption, customer/patient interactions, etc.
Education
- BA/BS degree
- JD highly preferred