Associate Director / Director, Compliance & Legal
The Associate Director/Director of Compliance & Legal will contribute to the development and implementation of compliance policies and practices, and work with senior Legal, Commercial, Medical, Clinical Development, Finance and HR leadership to integrate, support and monitor appropriate healthcare, corporate, privacy and other controls to guide the Company’s operations. While the position is primarily a Compliance role, the ideal candidate would be able to contribute to legal matters such as contract drafting and negotiation as well as other key initiatives and projects. This position reports to the Vice President, Compliance and Legal.
- Assist in the implementation and management of compliance program and operations, including providing compliance oversight and participating, as required, in promotional review, review, approval and documentation processes for core Commercial and Medical activities: speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations.
- Support the ongoing compliance program by auditing and monitoring business activities, implementing process and system enhancements, and supporting remediation activities, as necessary
- Manage the transparency reporting program, including developing, reviewing, and submitting reports related to federal and state transparency (“Sunshine”) laws.
- Monitor the business activities and industry compliance best practices to evolve the compliance program through ensuring appropriate practices, processes, systems and tools are in place and maintained to support the business at all times.
- Assist in providing compliance education, including both new hire, and ongoing training and be an ambassador for communication around key compliance topics, resources, and special initiatives
- Assist Finance/HR in preparing confidential reports
- Assist in preparing and reviewing legal contracts and maintenance of same, including agreements with healthcare providers and conducting debarment and exclusion checks
- Assist Market Access in facilitating state virtual manufacturing licensing activities
Education and Experience:
- Bachelor of Arts or Bachelor of Science required
- A minimum of 4 years of biopharmaceutical industry experience in a relevant compliance/legal function, with extensive experience with a commercial stage pharmaceutical or biotech company
- Knowledge of and proficiency with laws and regulations applicable to pharmaceutical companies, US fraud and abuse and false claims laws, U.S. transparency laws and regulations, privacy laws, and PhRMA Code on Interactions with Healthcare Professionals US transparency laws and regulations, privacy laws, and other laws and regulations related to the development and commercialization of pharmaceutical products
- Working knowledge and previous experience in a compliance operation
- Excellent interpersonal, communication and written skills, proven ability to work independently with a wide range of stakeholders
- Strong presentation and training skills and ability to work independently
- Strong internal (employees) and external (partners; vendors) collaboration skills
Skills, Abilities and Expertise:
- You thrive in small company environments and know how to maximize resources. You have an entrepreneurial mindset and approach to business challenges
- You are passionate about your work and display a high level of emotional intelligence in your decision making. You are an optimistic role model even in the face of obstacles to success
- You possess strong collaboration skills and can influence internal and other decision-makers
- You possess excellent communication and interpersonal skills with the ability to set direction and build consensus among individuals from a variety of cultures and disciplines.
- You have strong thought leadership, strategic thinking, problem solving and analytical skills with demonstrated ability to identify business issues and opportunities
- You strive for excellence and expect the same from your team and colleagues
- Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
- Commitment to Patients: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
- Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
- Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
- Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
- Empowered Communications: You possess and demonstrate strong communication and interpersonal skills.
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining a diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.