Qc Specialist

1 week ago

Johannesburg South, South Africa Arborvitae.in Full time

REPORTING MANAGER: ROLE: QC Specialist DESIGNATION: Senior Associate - Scientific Writing EDUCATION: Medical/M. Pharm./Pharm. D./life sciences degree EXPERIENCE: Minimum 4 years’ experience in medical writing or equivalent experience in life sciences domain. SKILLS: Outlook). - Knowledge of regulatory documentation, drug development and global regulations and guidelines. - Good written and verbal communication skills. - Good organizational and time management skills. - Good attention to detail and decision-making skills. PRINCIPAL RESPONSIBILITIES: - Responsible for performing QC review (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data within the document, Grammatical errors, typos, inconsistency/non-compliance to client style) of complex regulatory/safety documents such as Protocol, CSR, IB, Clinical Overviews & Summaries, Subject Narratives, Aggregate Reports, RMP-related documents and Subject Narratives. - Responsible for the entire life cycle of QC and accountable for maintaining quality and timeliness, and compliance with internal/client SOPs and regulations. - Ensure that QC process is compliant with client requirement/ global standards. - Upload and acknowledge observations into client portals for quality review and management system. - Update SOPs and other job aids for completeness as needed. - Control/reduce the cost, cycle time and error rates in projects. Review Content of Team Members: - Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check. Process Adherence and Compliance: - Be aware of all organisational, divisional and client-related policies and procedures related to quality, information security and data privacy. - Responsible for strictly adhering to quality standards for various deliverables as determined by the business unit or client. - Responsible for maintaining confidentiality and adhering to copyright rules for various deliverables/clients as per company norms. Self-Development: - Support in developing technical training programmes for other team members relevant to the job. - Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas. - Learn the basic skills to manage teams. - Participate in and contribute to various continuous improvement initiatives or company - driven initiatives. - Demonstrate flexibility in moving across new projects and preparing various document types. - Continuously enhance and maintain knowledge of various clinical/nonclinical & regulatory guidelines for different deliverables by doing various assignments. - Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest. **Job Types**: Full-time, Permanent

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