Senior Manager, Healthcare Compliance

Cytokineticsis 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. Youll enhance implement and maintain a risk-based compliance monitoring and oversight framework working across Compliance Legal and Internal Audit teams 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 will also support policy and procedure development training and compliance program 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.
• Bachelors 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.
  
  #LI-HYBRID

Pay Range:

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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain () and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at

Please visit our website at:

Cytokinetics is an Equal Opportunity Employer