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 Sr. Document Specialist, Global Records works with Global Records Manager to operationalize Records Management within Global R&D and the Trial Master File (TMF) Management and Records group ensuring the operational aspects are handled daily following GCP records processes to handle and maintain the required standards. Role will maintain awareness of requirements and best practices of current regulatory, legal, and other relevant guidelines such as data integrity and requirements such as records retention as well as corporate function requirements to carry out the goals of Records Management, such as applying legal holds, controlling records, and ensuring data protection.

The Sr. Document Specialist will assist in closure and archival of clinical studies, as necessary, and management of the storage systems and processes for both electronic and existing paper documents that will allow for identification and retrieval, transfer and migration, and archiving and defensible disposal of documents in support of the TMF records across the organization as well as with external contractors, partners and vendors. This person will work with other TMF Records stakeholders to ensure through training and issue resolution that we have uniform compliance in how records are stored, retrieved, refiled, archived, destroyed, and retained with high standards and minimal supervision. The Sr. Document Specialist may be called upon to act as archivist for the Global TMF records during inspections, audits, and other records management processes, as needed.

Key Responsibilities:

Continually improve and contribute to processes within Records and Information Management and associated business process, notifying manager and stakeholders on observed improvement opportunities and assist as directed by manager in converting improvement opportunities into realities.Operationalize Records and Information Management processes such as transfers, migrations, data integrity quality checks, eArchiving, disposition, and records access requests.Assist in drafting and updating Standard Operating Procedures (SOPs), Work Instructions and other controlled documents in support of the job function within processes of records and information management, discovering and documenting process improvements.Assist in processes to apply Legal Holds and comply with retention requirements of Global Records program based on corporate retention guidelines.Engage in activities to ensure the compliance of deliverables to applicable regulations, guidance requirements and internal client requests for records.Take ownership in awareness efforts and promote/educate employees on Records Management, associated business quality and compliance.Assist and train others on Global Records processes to classify, store, retrieve, refile, retain, archive and destroy records and information.Work with functional stakeholders and external third parties as needed to meet internal and external requests.Assist in periodic testing of the TMF processes and documents to ensure successful audits and inspections.Work to complete assigned project tasks and deliverables.Troubleshoot issues and bring them to completion, escalating as needed to ensure timely resolution.

Qualifications:   

High school degree with 6+ years of experience in Life Sciences Records Management and/or  Trial Master File Management or a college degree in Life Sciences, Records Management methodology, Scientific Library or Library and Information Sciences with 4+ years of experience in Life Sciences Records Management, especially Trial Master File Management.Experience of 4+ years in the pharmaceutical industryExperience of 1+ years in records and information management programs or projects like asset transfer, inventorying and quality check sampling.Must have a solid background in Veeva Vault.Must have a working knowledge and understanding of GXP/GCP Records Management principles, including retention requirements and systems utilized in records management and TMF in the pharmaceutical industry.Customer-centric, self-motivated, detail-oriented, ability to prioritize in consultation with manager, customers and stakeholders, and good interpersonal skills to effectively communicate in writing and orally with teammates and other peers.Advanced computer skills in MS Excel, MS Word, MS Outlook, and MS PowerPoint are vital. Knowledge of MS Teams, MS Visio and Adobe Acrobat are helpful.Ability to lift, drag, or carry boxes weighing up to 40 lbs./18 kg.

Travel:  10%-15%

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 Clarity

Salary Range: $74,900.00 - $109,900.00 annually

BeiGene 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.