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Compliance Specialist

Compliance Specialist

About us

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.

We are excited for our next Compliance Specialist to join the Viralgen team!

About the role

We are seeking a Compliance Specialist who will play a key role on the structure of the company.

The Compliance provides advice and guidance to the global functions of Viralgen regarding the Company’s Code of Conduct and Business Ethics, Corporate Compliance policies and standards, and other compliance issues and inquiries. Supports compliance with laws and regulatory requirements of local, state, and federal agencies, as well as the Company’s compliance policies and procedures.

Responsibilities

  • Manage the development and implementation of the Compliance plan designed to evaluate and enhance existing compliance programming to ensure compliance with policies, the laws and regulations and other regulatory guidance.
  • Responsible for establishing and revising existing policies and procedures to support the work plan.
  • Work closely with key stakeholders including Legal, Audit, Human Resources, Finance, Communications, Safety Health and Environment department to ensure effective implementation of compliance initiatives.
  • Serve as primary point of contact for business units for any compliance questions.
  • Reviewing, analyzing, and keeping current on relevant legal issues affecting the pharmaceutical and biotech industries. Providing updates to senior leaders and business clients on changes in legal issues affecting the pharmaceutical and biotech industries.
  • Identifying, participating and contributing to contract enhancement initiatives.
  • Proofread, edit and fact-check contract documents for completion, consistency, and accuracy.
  • Fostering a dynamic, communicative, and respectful work culture within the team and between different departments.

About you

  • Bachelor’s Degree in Law or similar.
  • Valuable at least 2-3 years of experience in Compliance area.
  • Technical proficiency in the field of compliance and data policy.
  • Knowledge in biotechnology is a plus.
  • Fluent in English and Spanish.
  • High level of written communication skills.
  • Proactive management and positive attitude to change and challenges.
  • Demonstrated ability to work in a multidisciplinary environment both independently and in a team environment.
  • Demonstrated ability to work well under pressure and meet tight deadlines.
  • Demonstrated passion for producing high-quality work.
  • Communication skills and self-management.