Quality Assurance Regulatory Specialist
2 weeks ago
A leading biotechnology organization is seeking a Regulatory Affairs Specialist (CMC) to enhance the Data Administration team. This position offers a hybrid work arrangement.
Key Responsibilities
- Conduct data entry utilizing internal systems to accurately input and maintain essential product details for cross-departmental collaboration.
- Collaborate effectively with the Regulatory Affairs CMC team to achieve project milestones and deadlines through diligent data entry and quality assurance of the information processed.
- Ensure the accuracy, completeness, and uniformity of data and its structural organization.
- Support project initiatives aimed at improving information systems for Regulatory Affairs CMC and the stakeholders who depend on this data.
- Develop and acquire necessary system expertise and knowledge, with training provided by management and colleagues.
- Work under the guidance of senior Regulatory Affairs CMC Systems professionals.
Required Qualifications
- Familiarity with data entry processes in intricate information systems is essential.
- Experience with web-based Electronic Data Capture (EDC) and data management platforms is preferred.
- Proficiency with Veeva Vaults is required, with experience in RIM Vault being advantageous.
- Strong verbal and written communication abilities, along with excellent interpersonal skills.
- Demonstrated organizational skills and the capacity to manage multiple projects simultaneously under tight deadlines.
Compensation:
- Salary range: $102,052 - $126,568
Why Consider R&D Partners?
As part of our team, you will benefit from a comprehensive package that includes:
- Medical insurance options including PPO, HMO & HSA
- Dental and Vision coverage
- 401k retirement plan
- Employee Assistance Program
- Long-term disability benefits
- Weekly payroll
- Expense reimbursement
- Online timecard management
R&D Partners operates as a global functional service provider and strategic staffing resource, specializing in scientific, clinical research, and engineering roles. We offer diverse job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors.
R&D Partners is committed to equal employment opportunities.
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