The Compliance Manager will review documents, grants and letters of agreement relative to
securing or discussing grant funding from pharmaceutical and device manufacturers to ensure
compliance standards have been applied. S/he will provide direct regulatory and compliance
support to several departments and will perform internal training and assessments relative to
regulatory affairs and compliance issues relative to business needs and objectives. The
Compliance Manager will contribute to the development and implementation of company practices
and policies for regulatory affairs and compliance. S/he will work to ensure optimal
strategic and operational synergy to support PMI recognition as a leader in providing programs
that are conducted within an optimal regulatory compliance framework. S/he will archive,
retrieve, and disseminate pertinent materials as related to regulatory affairs and compliance.
The Compliance Manager will work with others to publish evaluation, needs assessment, outcomes
and other clinical and regulatory affairs and compliance data. She/he will conduct compliance
assessments and implement an integrated and comprehensive program for achieving compliance
within recognized laws, regulations and policies.
Candidates must display demonstrated strategic planning, leadership, and management skills,
and must have demonstrated expertise in regulatory and compliance, medical or a related
business area. The role requires a Masters degree in a science specialty and a minimum of two
years industry experience. Ideal candidates will have an understanding of the relationships
between clinical and regulatory affairs and compliance activities related to medical
education, marketing and sales, and the commercial environment. Knowledge of FDA operations,
rules, regulations, the PhRMA Code and AMA, ACCME, and OIG guidelines is highly preferred.
This position is located in the Back Bay area of Boston, MA. For immediate consideration,
please email your cover letter and resume to: email@example.com . Please include
“Compliance Manager” in the email title when responding.
Visit us at http://www.mc-comm.com.