Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
This role establishes a country specific capability within the China CSM team and direct report to the manager of HGR management. The Senior HGR Specialist leads complex HGR application processes, ensuring strategic alignment with regulations and optimizing project start-up activities.
Responsibilities
- HGR Application and Maintenance Execution: Lead HGR application activities with comprehensive preparation, submission, and maintenance. Collaborate strategically with stakeholders (CSL, ASML, ASUL, CSSU COM, CRA COM, CSSU, CRA, and China R&D colleagues) to proactively resolve issues in HGR processes. Provide best practice guidance to junior specialists.
- HGR Submission Leadership: Drive the preparation and submission of complex HGR applications, ensuring detailed online data entry and dossier completion. Mentor junior specialists in handling sophisticated submission processes.
- Document Compilation and Submission: Oversee the compilation and submission of ethics and local document packages, ensuring thoroughness and compliance. Review work from junior specialists to maintain standards.
- Strategic Regulatory Compliance: Lead efforts to secure HGR, sample exportation, and CIQ approvals, ensuring robust alignment with regulatory bodies. Develop strategies to anticipate regulatory changes and ensure compliance.
- Regional Collaboration: Actively contribute to regional start-up calls, offering strategic site/study input. Manage the collection and quality assurance of essential site documents, coordinating with junior specialists for consistency.
- • Compliance and Data Management: Lead compliance initiatives by overseeing HGR data tracking and document archiving, implementing best practices for efficiency and precision. Develop effective solutions to resolve strategic issues innovatively while guiding junior specialists in addressing complex compliance challenges.
- Cross-Functional Leadership: Cultivate relationships with key stakeholders (CSL, ASML, ASUL, CSSU COM, CRA COM, CSSU, CRA, China R&D) to ensure strategic alignment in HGR activities. Promote cross-functional communication and collaboration.
- Process Innovation: Lead process optimization initiatives for improved efficiency and compliance, inspiring junior specialists to participate in enhancements.
- Mentorship and Training: Mentor junior team members, sharing expertise on complex HGR processes. Conduct training to elevate team skills and capabilities.
- Expertise Development: Maintain and grow professional expertise in HGR regulations and practices. Stay abreast of industry trends, sharing insights to keep the team informed.
Qualifications
- Educational Background: A bachelor’s degree in life sciences, medicine, pharmacy, health sciences, or a related field is essential. A master’s degree or Ph.D. in a related field is strongly preferred.
- Work Experience: A minimum of 5 years of experience in the pharmaceutical industry, with at least 3 years focused on human genetic resource management or related fields.
- Knowledge and Skills: Comprehensive expertise in HGR regulations, with proven application of ICH GCP and clinical trial workflows. Strategic thinking abilities to develop and implement optimization strategies for processes and regulatory alignment. Expertise in advanced data tracking systems and document management best practices.
- Leadership skills to manage and mentor junior specialists, fostering their development and team success. Strong problem-solving and risk mitigation skills to effectively address regulatory and operational challenges.
- Communication Skills: Excellent communication and interpersonal skills to maintain and enhance relationships with a wide range of stakeholders, including internal teams, external partners, and regulators. Ability to convey complex information clearly to facilitate cross-functional coordination and decision-making.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html