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 HGR Specialist is responsible for executing HGR application activities during the study start-up period, ensuring compliance with regulations and supporting efficient project operations.
Responsibilities
HGR Application and Maintenance Execution: Execute HGR application activities, focusing on the preparation and submission of applications. Collaborate with key stakeholders to ensure timely and high-quality delivery of HGR applications, addressing and communicating any issues that affect delivery.
- HGR Submission and Data Management: Assist in the preparation and submission of HGR applications, ensuring precise online data entry and dossier preparation.
- Document Compilation and Submission: Compile and submit all required ethics and local document packages, ensuring accuracy and adherence to compliance standards.
- Regulatory Compliance and Approvals: Support activities necessary for obtaining HGR and sample exportation approvals, ensuring alignment with regulations.
- Regional Collaboration: Help manage the collection of essential documents from sites, performing quality checks to ensure ALCOA compliance.
- Data Tracking and Archiving: Maintain detailed tracking of HGR applications and approvals, ensuring thorough documentation archiving for compliance.
- Compliance Monitoring: Monitor HGR compliance for assigned studies, resolving implementation issues with guidance from senior colleagues.
- Cross-Functional Collaboration: Work collaboratively with key stakeholders to ensure the HGR application process aligns with project goals, focusing on effective communication and coordination.
- Process Improvement: Identify opportunities for minor process enhancements and assist in their implementation.
- Knowledge Enrichment: Engage in training programs to stay updated on HGR regulations and industry best practices.
Qualifications
- Educational Background: A bachelor’s degree in life sciences, medicine, pharmacy, health sciences, or a related field is required.
- Work Experience: At least 2 years of experience in the pharmaceutical industry, preferably with exposure to human genetic resources.
- Knowledge and Skills: Solid understanding of human genetic resource regulations, including familiarity with ICH GCP and clinical trial workflows. Strong time management skills and attention to detail, with the ability to manage multiple tasks in a high-volume work environment. Proficiency in data tracking and documentation processes is advantageous.
- Communication Skills: Good communication skills to interact effectively with team members and external stakeholders, ensuring collaboration across projects.
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