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Manager/Senior Manager, Compliance

Legal

US-Emeryville, CA OR Remote

Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.

As a member of the legal and compliance team, this position will help lead the healthcare compliance efforts at Dynavax and reports to the Director of Compliance. The position is remote and reports into our Corporate Headquarters in Emeryville. 

Responsibilities

Develop and maintain the Policies, Training and Communication component of the Dynavax Compliance Program

  • Develop, draft, and carry out compliance policies and procedures and ensure all are up to date and accessible.
  • Participate in development and implementation of training strategy initiatives, including live web-based sessions and Learning Management System (LMS) content. Manage the creation of content and delivery of effective training to new and existing employees.
  • Analyze learning management system data and reports for completion and overdue training items to maximize compliance.
  • Lead and develop innovative and engaging training and communication plans; conduct periodic training.
  • Execute strategy and oversee compliance, ethics & integrity communications to support a strong culture of compliance and integrity, including development of materials for compliance campaigns, internal portals, webpages, newsletters, etc., and promoting awareness of the Compliance Hotline.
  • Partner with employees and leadership to maintain and further develop a strong culture of compliance throughout the organization, including personal accountability at all levels with a spirit of partnership, trust, and transparency.
  • Work closely with key stakeholders including Legal, IT, Human Resources, Finance, Communications, Drug Safety and other departments, to ensure effective implementation of compliance initiatives.
  • Provide compliance support across the organization working with colleagues in commercial, medical affairs, clinical, regulatory, finance, and other departments to complement existing compliance activities, including identifying practical solutions that balance the risk/benefit for the company.
  • Execute strategy and assist with enhancing and continuous improvement of a best in practice Compliance Program.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Assist with developing, implementing, and improving processes and systems to increase the efficiency of the compliance department.
  • Serve as the primary point of contact for business units for any compliance questions.
  • Assist and support other functions of Compliance Program as needed.
  • Other duties as assigned.

Qualifications

  • 5-7 years of Pharmaceutical, Healthcare or relevant agency experience including compliance program management.
  • Minimum of 4 years of compliance experience, preferably in the biopharmaceutical or medical device industry.
  • Strong knowledge of compliance requirements in a highly regulated industry, and an ability to apply them in a way that is reflective of the business need but also ensures compliant business conduct.
  • Industry knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, Anti-kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals and current activities and developments involving pharmaceutical sales and marketing.
  • Must be an analytical and strategic thinker with an ability to interpret laws, regulations, and industry guidelines and conceptualize policies and procedures.
  • Demonstrated leadership skills, including ability to lead change efforts through effective communication and persuasion.
  • Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required.
  • Ability to work effectively with, influence and get consensus across functional units and at all levels in the organization as well with external parties.
  • Proven ability to make sound judgments and decisions. Able to quickly assess problems/situations and provide effective resolutions/solutions.
  • A “can do” professional who will work proactively with both internal and external resources to drive results.
  • Excellent interpersonal skills and the ability to build and maintain positive work relationships and effectively interface across the organization.
  • Excellent communicator – both verbal and written - with business acumen and the ability to consistently meet or exceed project deadlines.
  • Flexible, high level of integrity, action and goal oriented.
  • Ability to stand or sit for prolonged periods.
  • Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
  • Occasional travel required, as needed.
  • Full COVID-19 vaccination is required for this position.

Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.