Manager, Quality Control

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 documents such as clinical study reports, protocols, and protocol amendments; experience in reviewing or copyediting clinical sections of INDs, MAAs, and NDAs is a plus.

• A thorough understanding of the general processes of drug/biologics development as well as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines.

• Experience developing and maintaining document templates, style guidance, and process documentation.

Education Required:

• BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.

• At least 5+ years of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor. Management experience is preferred.

Supervisory Responsibilities:

• Manages and supervises staffing and performance management, including, but not limited to, hiring, training, coaching, and conducting performance reviews for direct reports, if applicable.

Computer Skills:

• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint.

• Proficiency in navigating Microsoft Windows.

• Proficiency or familiarity with SharePoint and Veeva Vault is preferred.

Other Qualifications:

• Effective Communication: Communicates critical information to key stakeholders with clarity, precision, and conviction. Proactively escalates questions/issues to appropriate stakeholders at an early stage. Takes part in discussions with different viewpoints, and proactively provides value-added inputs.

• Embracing Change: Always seeking and open to new opportunities and changes. Be able to execute new and different solutions when faced with new challenges. Embraces change and quickly alters course in response to new challenges. Leads change efforts management within the department and across functions.

• Creating Innovation: Anticipates the need for and adopts new methods and practices. Generates innovative ideas and new approaches for addressing a range of work areas; encourages others to generate ideas.

• Thinking Strategically: Understands how concepts (eg, strategic review, lean writing) relate to the future objectives and aims of the department, and identifies the principles for new concepts. Leads (part of) the establishment of clear and effective strategies for the department, and contributes to the establishment of clear and effective strategies for cross-functions, based on an in-depth understanding of industry trends and company mission.

• Mentoring: Provides feedback related to individual and department to support ongoing development and overall department performance as needed. Finds opportunities to individually coach others, providing specific insights and tips to enhance skills, knowledge, or work performance.

Travel: N/A

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.