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Entrada Therapeutics · 1 day ago

Vice President, Head of Compliance, Legal

Boston, MA

Full-time

Hybrid

Director/Executive

$325K/yr - $380K/yr

10+ years exp

Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform patients' lives through innovative medicines. The Vice President of Compliance will be responsible for designing and overseeing a comprehensive compliance program, ensuring adherence to laws and ethical standards across all company operations.

BiotechnologyEmergency MedicineGeneticsHealth CareMedical

Responsibilities

Lead the design, implementation, and management of a robust compliance program, ensuring alignment with regulatory requirements, company policies, and industry best practices

In close collaboration with other members of the legal team, regulatory affairs, medical affairs, and quality, create and oversee the implementation of a fit for purpose & fit for stage compliance strategy appropriate for a precommercial organization

Monitor and interpret changes in relevant laws, regulations, and guidelines (e.g., FDA, EMA, OSHA, HIPAA, GDPR, DEA), providing timely legal and regulatory insight and guidance to the organization

Establish and maintain policies and procedures to ensure compliance with standards governing clinical trials, pharmacovigilance, data protection, product safety, communications, and commercialization

Conduct regular compliance risk assessments and audits; report findings and recommend corrective actions to the Legal department and senior management

Lead internal investigations of potential compliance violations and manage responses to regulatory inquiries or inspections, in collaboration with legal counsel

Develop and deliver compliance training and education programs for employees at all levels, integrating legal and regulatory perspectives

Serve as the primary point of contact for regulatory bodies, external auditors, and legal counsel on compliance matters

Collaborate with Medical Affairs, Clinical Development, Commercial Operations, R&D, Regulatory Affairs, Quality Assurance, Supply Chain, and Human Resources to ensure coordinated compliance efforts

Prepare and present regular compliance reports

Foster and promote a culture of ethical conduct, integrity, and transparency throughout the organization

Qualification

Compliance program managementRegulatory affairs expertiseLegal knowledge FDALegal knowledge EMAJuris Doctor (JD) degreeCompliance certifications CCEPCompliance certifications RACBiotechnology sector experienceAnalytical skillsProfessionalismInterpersonal skillsProblem-solving abilitiesCollaboration skillsIntegrity