Senior Manager, Healthcare Compliance

Cytokinetics; Philadelphia (Philadelphia County); In loco; USD 175.000 - 205.000; Tempo pieno

Descrizione del lavoro

Cytokinetics is seeking a Senior Manager of Healthcare Compliance to join its Compliance organization. This in-office role will be based in Radnor, PA or South San Francisco, CA, with regular travel up to 25%.

You will develop and maintain a risk-based compliance monitoring framework across Compliance, Legal, and Internal Audit, ensuring alignment with regulatory requirements and company policies. You will lead compliance training, prepare monitoring reports, and serve as a partner to internal

Competenze

• Demonstrated expertise in pharmaceutical/life science & health law compliance required.
• Bachelor’s degree as stated.

Mansioni

• Develop, implement, and maintain a risk-based compliance monitoring and oversight program across Compliance, Legal, and Internal Audit teams.
• Travel nationwide up to 25% to monitor field activities and trainings.
• Coach and provide compliance guidance to Field-based personnel.
• Prepare summaries and reports of monitoring results, risk assessments, and training outcomes.

Conoscenze

Healthcare compliance

Regulatory knowledge

Communication skills

Analytical skills

Training and coaching

Project management

Travel readiness

Formazione

Bachelor's degree in Finance, Business, Law, Compliance, or related field

Descrizione del lavoro

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 preferred.
• Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility.
• Excellent communication skills, both oral and written.
• Excellent analytical skills, with a strong ability to draft and review documents, analyze and provide compliance guidance, and apply policy guidance to business needs.
• Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper ethical and compliance standards.
• Team-oriented, sound judgment, self-motivation and willingness to take initiative.

Pay Range

The expected salary range for this position based on the primary location of Radnor, PA is $175,500-$204,750. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer