Compliance Operations Manager
Company: SpringWorks Therapeutics
Posted on: September 24, 2022
About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical
company applying a precision medicine approach to acquiring,
developing, and commercializing life-changing medicines for
underserved patient populations suffering from devastating rare
diseases and cancer. SpringWorks has a differentiated portfolio of
small molecule targeted oncology product candidates and is
advancing two potentially registrational clinical trials in rare
tumor types, as well as several other programs addressing highly
prevalent, genetically defined cancers. SpringWorks' strategic
approach and operational excellence in clinical development have
enabled it to rapidly advance its two lead product candidates into
late-stage clinical trials while simultaneously entering into
multiple shared-value partnerships with industry leaders to expand
This role will be reporting to the company's Compliance Officer,
the Compliance Operations Manager will execute aspects of the
operations of SpringWorks' global healthcare compliance & ethics
program. The Compliance Operations Manager will work
cross-functionally supporting the Compliance, Privacy, and Legal
Team operations including processes and systems.
Your Essential Role & Responsibilities:
- Support the Compliance function's operational objectives and
various special projects with a goal of ensuring that SpringWorkers
adhere to the highest legal and ethical standards in all business
- Help develop policies, procedures, and processes utilizing
existing systems and new, innovative, tools and technology to
further the company's mission and streamline operations
- Create trainings, leveraging systems, and currently internal
- Track and compile records of training using internal systems
and centralized documentation. Provide regular training updates,
status reports, and scorecards 'training metrics' for the
Compliance, and Privacy organizations.
- Help Support communication programs, and disclosure program
awareness initiatives to enable all SpringWorkers to seek
assistance, make suggestions, raise concerns or identify issues
- Support compliant interactions between field personnel,
healthcare professionals (HCPs), and other customers through
appropriate training and communication of policies, procedures and
- Work at the direction of the Compliance & Privacy Leadership to
ensure that all compliance concerns or reports of compliance
violations as well as privacy matters are investigated and resolved
or properly reported.
- Assist in the management of compliance and legal operations
mechanisms to meet the needs of the company as it prepares for
commercialization, including without limitation, processes for
debarment/exclusion screening, Sunshine Act reporting, state
compliance reporting, privacy law compliance, FCPA/Anti-Bribery and
fraud and abuse compliance, auditing / monitoring of healthcare
participant-facing field roles, evaluating payments to HCPs against
fair market value standards and oversight of the company's
- Assist with Legal Department operations as needed, including
with various projects assigned by the Company's attorneys.
- The position requires periodic travel for training, meetings,
and field monitoring.
- Project and system management
- Vendor management from selection, onboarding, and regular
engagement with vendor
Your Education & Experience:
- Bachelor's degree.
- 3+ years' experience in international / US healthcare
compliance in the biopharmaceutical industry, including providing
compliance advice or support, playing key roles in supporting
compliance training to pharmaceutical/biotech companies including
experience with learning management systems (LMS) and/or training
- Launch preparation and experience preferred
- Knowledge of healthcare laws and regulations, including the
False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA,
and privacy laws and regulations.
- Understanding and hands on experience with policies, procedures
and process for spend capture, transparency, and Sunshine Act.
- Must possess a strong sense of ownership and responsibility, as
well as a proven work ethic delivering excellent work product and
exemplary customer service.
- Demonstrates passion for the business and this role; espouses a
collaborative approach; leads by example in setting a positive tone
for the compliance function.
- Ability to influence key stakeholders and drive decisions.
- Must be able to present to and work effectively with a
- Excellent communicator in both the written and oral form;
understands how to approach communication from a strategic
- Promotes ideas and new proposals persuasively; works through
conflicts and difficult situations.
- Cultivates internal relationships and relates well to key
colleagues at all levels
Are you a SpringWorker?
How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?
At SpringWorks Therapeutics, we ignite the power of promising
science to unleash new possibilities for patients. We work hard, we
care even harder and we're in it together. We are looking for
ambitious, smart, and hardworking colleagues to join our growing
SpringWorks Therapeutics is an Equal Employment Opportunity
employer. All qualified applicants/employees will receive
consideration for employment without regard to that individual's
age, race, color, religion or creed, national origin or ancestry,
sex (including pregnancy), sexual orientation, gender, gender
identity, physical or mental disability, veteran status, genetic
information, ethnicity, citizenship, or any other characteristic
protected by law.
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Keywords: SpringWorks Therapeutics, Stamford , Compliance Operations Manager, Executive , Stamford, Connecticut
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