Manager, Quality Control
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Manager, Quality Control (QC), is responsible for the oversight, coordination, and completion of assigned QC reviews, ensuring that clinical and regulatory documents undergo review, copyediting, data verification, and proofreading in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical and regulatory documents include study reports, clinical study protocols or amendments, investigator’s brochures, and the clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Global Medical Writing that require a QC review.
This work can be done remotely or from any of BeOne’s global offices.
Essential Functions of the Job:
Document Review and Editing:
-
Works effectively within the Global Medical Writing group to produce high-quality, scientifically accurate documents under strict timelines, ensuring consistency between related documents.
-
Applies knowledge of industry standards, regulatory requirements, and internal procedures to ensure document quality and compliance, occasionally requiring prioritization and management of multiple parallel projects.
-
Ensures compliance with Global Medical Writing conventions, processes, and applicable regulatory guidelines.
-
Reviews documents for content completeness, logical consistency, clarity, readability, and adherence to established standards and templates.
-
Identifies gaps, inconsistencies, and missing information and collaborates with document authors to resolve issues before document finalization.
-
Applies knowledge of industry standards, regulatory requirements, and internal procedures to ensure document quality and compliance.
Project and Process Management:
-
Manages team direction and strategy in collaboration with other QC and Global Medical Writing team leaders.
-
Manages QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
-
Able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands.
-
Partners with document authors and stakeholders to address revision requests and drive efficient resolution of review comments.
-
Contributes to the development, maintenance, and continuous improvement of QC processes, templates, guidance documents, and best practices.
Influence and Training:
-
Engages in trainings that will improve authoring and technical editing skills and expand knowledge of the Global Medical Writing team or other areas of the company (cross-training programs, mentoring programs, etc).
-
Supports onboarding and mentoring of new QC team members and promotes consistency in review practices across the team.
-
Serves as a resource for resolving complex editing, formatting, and quality-related issues.
Qualifications:
-
Demonstrated ability to communicate in clear, concise, and effective English in both written and verbal forms.
-
Experience directly mentoring and managing other team members; completion of management-related training modules or other hands-on management experience; a proven desire to take on management-level responsibilities, including helping to develop team members and effectively assess the performance of at least one direct report.
-
Extensive experience in conducting QC review or copyediting of pharmaceutical industry regulatory