Quality Control Specialist, Medical Writing

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 QC Specialist is responsible for coordinating and completing 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 department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.
• Responsible for performing a quality check of clinical and regulatory documents before approval.
  • Performs cross-referencing, fact-checking, and general quality assessments of documents.
  • Proofreads documents for grammatical and formatting errors, hyperlink functionality, data source verification, and proper translation of data.
  • Ensures compliance with Global Medical Writing conventions, processes, templates and applicable regulatory guidelines.
• Maintains strong attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing technical edits.

Project and Process Management:

• Ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality QC reviews according to tight timelines and shifting priorities/demands.
• Adheres to QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
• Contributes to team direction and strategy discussions, with guidance from managers and mentors.

Influence and Training:

• Builds effective partnerships with all intradepartmental teams when collaborating on QC reviews and projects.
• Engages in trainings that will increase knowledge of medical writing, the types of documents in the scope of the Global Medical Writing team, medical terminology, and the development of drugs and biologics.

Qualifications:

• Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
• Experience in conducting medical writing QC reviews of pharmaceutical industry regulatory documents (such as clinical study reports, protocols, and protocol amendments) or experience in technical editing in a related or similar industry; experience in reviewing clinical sections of INDs, MAAs, and NDAs is a plus.
• Familiarity with the general process of drug/biologics development as well as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines is preferred.

Supervisory Responsibilities:

Not applicable for this role.

Other Qualifications:

• Effective Communication: Explains own work clearly. Able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from manager/mentor. Takes part in discussions with different viewpoints, and be able to provide value-added inputs with guidance from manager/mentor.
• Embracing Change: Always seeking and open to new opportunities and changes. Copes well with change and new challenges with guidance from manager/mentor. Contributes to specific change activities.
• Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work to improve time management, timeliness, and accuracy.
• Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work with guidance from manager/mentor. Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).
• Mentoring: Provides specific feedback to others within own team as requested. Solicits feedback and accepts and integrates changes from constructive criticism. Willingly shares own knowledge and experience to support others’ learning.

Computer Skills:

• Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat.
• Proficiency in navigating Microsoft Windows.
• Familiarity with SharePoint and Veeva Vault is a plus.

Travel:

Not applicable.

Education Required:

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

At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .

Originally posted on Himalayas