Senior Specialist Human Genetic Resources HGR Management
Senior Specialist Human Genetic Resources HGR Management
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Job Description
- HGR Application and Maintenance : 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 startup 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.KL1
- CrossFunctional 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 crossfunctional 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.
Previous statements for your reference:
6. Advanced Data Management: Oversee HGR data tracking and document archiving implementing best practices for compliance. Develop systems to enhance data management efficiency and precision.
7. Compliance Strategy and Resolution: Lead compliance initiatives with study teams resolving strategic issues with innovative solutions. Guide junior specialists in tackling complex compliance challenges.
Qualifications :
- Educational Background: A bachelors degree in life sciences medicine pharmacy health sciences or a related field is essential. A masters 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 problemsolving 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 crossfunctional coordination and decisionmaking.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Employment Type :
Fulltime
Employment Type
Full-time
