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Sr. Compliance Manager/Principal Compliance Manager

South San Francisco, CA 94080

Posted: 09/02/2023 Employment Type: Contract Job Category: Medical Affairs Job Number: 583664 Is job remote?: No Country: United States

Job Description

The Sr./Principal Compliance Manager is a member of the U.S. Medical Affairs Compliance (gMAC) team and provides trusted compliance guidance for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and healthcare compliance-related activities that impact U.S. Medical Affairs. This position works closely with other members of gMAC, U.S. Medical Affairs functions, and other compliance teams (i.e., Healthcare Compliance Office (HCO), Experience and Engagement Compliance (XEC), Global Product Strategy, Group Audit and Risk Advisory, Product Development Quality, Pharma HCO, etc.) to advance innovative, patient-focused solutions. The Sr./Principal Compliance Manager develops Medical Affairs procedures that are aligned with global and local regulations and policies, designs medical and healthcare-related monitoring strategies for U.S. Medical Affairs, and ensures communication regarding quality and compliance throughout the U.S. Medical Affairs organization.

gMAC is responsible for providing further business direction to U.S. Medical Affairs staff through the development of business-facing process documents (i.e., standard operating procedures [SOPs], working documents, job aids, etc.) and ensuring U.S. Medical Affairs staff understands how to apply corporate and global policies and processes. The function also ensures U.S. Medical Affairs is in compliance through proactive selected monitoring and improvement efforts, and understanding audit results and deploying needed corrective actions.

  • Understands the organization, including global and U.S. Medical Affairs GCP/GVP policies and guidelines, healthcare compliance policies, and U.S. Medical Affairs organizational dynamics
  • Partners with the business to develop and maintain U.S. Medical Affairs and business-facing SOPs, working documents, job aids, etc.
  • Provides compliance subject matter expertise to the U.S. Medical Affairs organization, both proactively and in response to inquiries
  • Participates in Study Management Team (SMT) meetings and is a strategic partner for study teams with medical and patient-related compliance questions
  • Supports routine and ad hoc audits to monitor and track internal and external compliance with U.S. Medical Affairs processes, as well as governing laws and regulations.
  • Includes implementation of appropriate corrective action and preventative action plans (CAPAs)
  • Partners with the HCO and the business to proactively mitigate risks and develop monitoring strategies to monitor and track emerging trends in medical affairs compliance
  • Generates compliance related metrics and data to drive continuous improvement efforts
  • Develops targeted, effective and efficient compliance training for U.S. Medical Affairs
  • Effectively leads and participates on cross-functional initiatives, working groups and project teams
  • Develops and delivers effective communications to promote compliance awareness and policy/process changes within U.S. Medical Affairs

  • Works with gMAC leadership to contribute to short- and long-term departmental objectives, plans, programs, projects and budgets for quality related efforts
  • Maintains current knowledge and understanding of products, medical and business strategies, and external factors that could potentially impact gMAC and medical affairs practices
  • Provides guidance and coaching to gMAC team members

  • Bachelors Degree required in Life Sciences or other relevant technical disciplines
  • Advanced degree in life sciences or other relevant technical disciplines strongly preferred
  • 7+ years of multi-disciplinary experience in the biotechnology / pharmaceutical industry
  • 5+ of experience in working with medical compliance principles, guidelines and regulations
  • Previous work-experience gained at large, global pharmaceutical organizations, preferably in Medical Affairs or another compliance-related function, is strongly preferred

  • Demonstrated previous experience with cross-functional problem solving and driving change through to successful implementation
  • Demonstrated experience with prioritizing and management of high-level initiatives and projects
  • Demonstrated ability to influence and lead both with and without authority; leading innovation and change; and excellent problem solving and decision-making skills
  • Must demonstrate knowledge of, or strong aptitude to learn, the legal and regulatory environment as it relates to the pharmaceutical/biotech industry Advances bold ideas for exponential improvement, including when faced with initial resistance
  • Trusts and empowers team members to deliver results
  • Demonstrates full and complete mastery of the E4 Compliance Manager responsibilities

  • Demonstrated experience in building and leading teams; coaching and developing others
  • Demonstrated experience in strategic planning
  • Effectively and constructively challenges the status quo, identifying better ways to streamline processes and enable business excellence
  • Exhibits professional maturity, confidence, and competence when leading
  • Global and Local projects with high visibility
  • Strong conflict resolution and negotiation skills; proven ability to effectively and quickly achieve positive outcomes
  • Demonstrates full and complete mastery of the E5 Sr. Compliance Manager responsibilities

  • Understands and navigates through organizational dynamics, particularly as they relate to quality and compliance Understands life sciences regulatory and compliance landscapes Impeccable work ethic and commitment to integrity and quality
  • Excellent problem solving and decision-making skills
  • Ability to work independently and with minimal supervision Precise attention to detail
  • Ability to handle complex business situations and obstacles in a systematic and/or creative manner that produces useful alternatives and solutions
  • Excellent interpersonal and partnering skills; ability to work collaboratively/effectively with internal & external partners/stakeholders and cross-functional teams
  • Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity
  • Strong analytical skills and capabilities
  • Demonstrable project management skills; proven ability to manage multiple tasks to conclusion, within allotted timelines/deadlines, and without compromise to quality of work output
  • Working knowledge of core business practices, principles, procedures, processes and primary business tools
  • Excellent communication skills, both written & verbal
  • Excellent presentation skills 

Pay Rate Range: $50-$80/hr. Salary will be commensurate with experience
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