BeiGene 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 Quality Control Specialist, Medical Writing Quality Control, is responsible for coordinating and completing Quality Control document assignments and ensuring that clinical 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 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 include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Medical Writing that require a Quality Control review.
This work can be done remotely or from any of BeiGene’s North American offices.
Essential Functions of the Job:
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 regulatory documents before approval.
Perform cross-referencing, fact-checking, and general quality assessments of documents.
Proofread documents for grammatical errors, formatting errors, hyperlink functionality, data source verification, and proper translation of data.
Manage QC timelines and communicate with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
Review and edit documents written or supported by the Global Medical Writing department.
Ensure compliance with Medical Writing conventions, processes, and applicable regulatory guidelines.
Qualifications:
Knowledge and Skills
Demonstrated ability to communicate in clear, concise, and effective English in both written and verbal forms.
Strong project management skills: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands.
Maintain consistent attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing high volume, repetitive tasks.
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 key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines.
Working knowledge of the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) is preferred.
Ability to ensure reviewed documents comply with company and/or industry style guides and templates.
Independently motivated with good problem-solving skills.
Excellent interpersonal skills; a team player.
Education/Experience Required
BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus, but not required.
At least 3+ years of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.
Supervisory Responsibilities:
Not applicable for this role.
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 and familiarity with SharePoint file systems is a plus.
Proficiency or familiarity with Veeva Vault is preferred.
Other Qualifications: N/A
Travel: N/A
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range: $66,300.00 - $91,300.00 annuallyBeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.