Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
We are seeking a Senior Manager of Healthcare Compliance to join our Compliance organization. This position will play a critical role in ensuring the effectiveness of Cytokinetics’ healthcare compliance program. You’ll enhance, implement, and maintain a risk-based compliance monitoring and oversight framework, working across Compliance, Legal, and Internal Audit teams globally. Your work will drive continuous improvement, support legal and regulatory requirements, and serve an essential part of the 7 Elements of Effective Compliance Programs for Pharmaceutical Manufacturers. You will also support policy and procedure development, training and compliance program administration.
This position will report to the Director, Healthcare Compliance. This is an in-office role only based either in our South San Francisco, CA or Radnor, PA office with expectation for regular work travel up to 25%.
Responsibilities
Expert understanding of the laws, regulations, industry standards, and guidelines for interactions with healthcare professionals and other Ethical codes and regulations
Develop, implement, and maintain a risk-based compliance monitoring and oversight program across Compliance, Legal, and Internal Audit teams
Travel nationwide to participate in live monitoring of field activities, including field rides, speaker programs, advisory boards, congresses, and symposia
Coach and provide compliance guidance to Field-based personnel
Manage the design and execution of compliance monitoring activities, including thematic reviews, continuous monitoring, and targeted desktop assessments across various business functions to assess adherence to corporate policies, regulations, and industry standards.
Design and implement a compliance Monitoring and Oversight framework, ensuring alignment with regulatory expectations and internal policies
Develop, assign, coordinate, and track compliance-related training for employees across functions. Identify training gaps and create targeted training content to address knowledge needs
Serve as an accountability partner for managing, maintaining, documenting, and dispatch of all Compliance-training materials, policies, or content
Prepare summaries and reports of monitoring results, compliance activities, risk assessments, and training outcomes, maintaining compliance documentation in an organized manner
Partner with all Company internal clients to clarify and help validate data and prepare reports and filings for transparency “Sunshine Act” data for final attestation by the Chief Compliance Officer
Oversee, manage, and engage in continuous improvement, review, drafting, and project management for all Compliance-specific policies, SOPs, guidelines, and work instructions
Support issue management processes and promote a strong culture of compliance across the organization
Partner and collaborate, as appropriate and applicable, with Legal colleagues
Keep apprised of applicable federal, state, and local laws, industry codes and regulations and apply them to areas of responsibility
Qualifications
Demonstrated expertise in pharmaceutical / life science & health law compliance is required. Minimum of 6+ years of experience in biotechnology, pharmaceutical, or life science related matters.
Bachelor’s degree in Finance, Business, Law, Compliance, or a related field.
Demonstrated experience conducting field monitoring for a commercial health science organization
Ability to travel (estimated 25% within a year).
Experience with training and/or monitoring and analytics in the bio/pharma industry preferred.
In-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry…