Sr Quality Review Specialist
Proclinical is recruiting for two positions with an international biopharmaceuticSenior Quality Review Specialist of Regulatory Documentation and Submissionsal company located in Foster City, CA. Successful candidates will provide various services including, but not limited to: quality reviews (data/content verification and consistency, style application, editing), audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications.
- Perform high-quality reviews of regulatory deliverables.
- Function as the RDS Quality Lead for various regulatory deliverables.
- Assist in audit preparation.
- Support RDS Quality initiatives.
- Act as a departmental RDS Quality resource.
- Performs detailed and thorough quality reviews to ensure data integrity, internal content consistency, completeness on a wide range of regulatory deliverables (CSRs, IB/Updates, CTDs, PK/Pop PK reports, etc) in accordance with Gilead RDS Quality standards and tools.
- Performs editorial reviews to ensure style is consistent with the R & D Manual of Style and within regulatory deliverable.
- Serves at the primary RDS Quality point-of-contact for assigned deliverables, monitors timelines, communicates with Lead Writer to ensure review expectations are understood and met, and alerts Lead Writer in a timely manner if deliverable is at risk.
- Participates in RDS Quality team meetings presenting timelines and updates of assigned deliverables alerting team of any potential resourcing issues.
- Advises on deliverable review strategies.
- Able to forecast individual project workload and proactively identify and communicate potential workload peaks.
- Closely collaborates with Audit SME and Lead Writer to support audit preparation by gathering documents and performing quality review to ensure audit package is complete and accurate.
- Assists with the development and delivery of relevant training and new hire o on boarding programs.
- Participates in development and/or revision of internal policies and procedures impacting quality standards and tools.
- Contributes to the development and maintenance of applicable standard operating procedures, manuals, and work practices.
- Responds to general Quality questions, helps train writers on review process and expectations, and remains current with Gilead and industry Quality standards.
- Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate.
Skills and Requirements:
- BS degree required.
- 4+ years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, including a minimum of 2 or more years of relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions.
- Ideal candidates include those who are familiar with Phase 1 to 3 clinical protocols and study reports and understand the drug development process leading to marketing applications
- Has well developed computer skills including proficiency in Word, Adobe and Excel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.