Senior Director, Compliance and Legal Operations
Company: Vericel Corporation
Location: Cambridge
Posted on: May 12, 2022
Job Description:
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application.Senior Director, Compliance and Legal Operations The
Senior Director, Compliance and Legal Operations reports directly
to the SVP, General Counsel and is responsible for the day-to-day
leadership, operations, and program management of the Compliance
program for Vericel. The position will provide oversight of
compliance operations, which includes but not limited to
monitoring, training, policies and procedures, communications,
third party due diligence, investigations, risk assessment and
reporting. The Senior Director, Compliance and Legal Operations
also serves as the main contact and compliance lead for the
commercial and medical organizations within Vericel, as well as a
primary contact for all parts of the business with respect to
day-to-day contracting needs and other operational matters of a
legal nature. ESSENTIAL FUNCTIONS
- Lead Compliance team and continue to build an effective and
scalable compliance program.
- Have a deep understanding of healthcare compliance laws,
regulations, and industry codes of practice governing
biopharmaceutical industry business practice including but not
limited to commercial, medical affairs, market access, and clinical
development activities.
- Keep apprised of legislative and regulatory developments on
areas of compliance vulnerability and risk.
- Have in-depth knowledge of anti-kickback prohibitions as they
apply to commercial activities, off-label promotion prohibitions,
and other primary laws governing key biotechnology compliance
areas.
- Establish effective working relationships and build credibility
within the Company, especially at senior management and operational
leadership levels, implementing a culture of trust, integrity,
transparency, and openness. -
- Assist the SVP, General Counsel in long-term strategic planning
for the compliance program in response to effectiveness measures,
continuous evolution activities and industry-leading best practices
for effective compliance programs. Remain abreast of industry best
practices and changing standards.
- Responsible for the compliance training program, including
developing, launching and monitoring online and live training
campaigns.
- Responsible for internal investigations procedure and conduct
internal investigations.
- Develop and execute monitoring plan to monitor in-person and
transactional business activities.
- Serve as a trusted compliance advisor to the commercial and
medical organizations.
- Supervise and manage direct report to help run the compliance
program.
- Support Vericel's data privacy and protection efforts.
- Oversee implementation and maintenance of company's contracts
database.
- Serve as a primary legal contact for all parts of the business
with respect to day-to-day contract needs.
- Provide support on all other matters requested by the General
Counsel or other members of the Legal team, including with respect
to litigation matters, as needed.
- Supervise external legal counsel on all of the above matters.
QUALIFICATIONS, EDUCATION AND EXPERIENCE Leadership Qualifications:
An ongoing commitment to conducting our global business according
to the highest legal and ethical standards, and to continually
pursue excellence in the development and delivery of all of our
products and services. This includes:
- Respecting the laws and operating within the applicable
regulations of the places in which we conduct business, as well as
our own Company policies and procedures.
- Being honest and treating people with respect and
courtesy.
- Constantly striving to make Vericel a great place to work, and
a company respected for the quality of its people and
products.
- Acting as role models for our fellow employees by acting
responsibly, fairly, and honestly in our dealings and exercising
sound judgment in performing our jobs. Basic Qualifications:
- Bachelor's degree, Advanced degree (e.g., JD/MA/MS/MBA),
Healthcare Compliance Certification and further experience in
Healthcare and Corporate Compliance, Finance, Auditing is
required.
- 10+ years of experience in corporate compliance in the medical
device, pharmaceutical or biotech industry at companies with a
marketed, commercial product.
- Knowledge of Health Care Compliance programs and policies,
Federal health care programs, and FDA requirements required.
- Highly familiar with current US life science marketplace,
substantive knowledge of applicable US laws relating to healthcare
and pharmaceuticals, auditing, experience developing and
implementing new policies, practices and related systems (i.e.,
CRM, Aggregate Spend)
Keywords: Vericel Corporation, Cambridge , Senior Director, Compliance and Legal Operations, Executive , Cambridge, Massachusetts
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