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Senior Document Specialist, Global Records

Company: BeiGene
Location: Lansing
Posted on: September 22, 2022

Job Description:

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 the TMF Management group ensuring the operational aspects are handled daily and GCP records processes to handle and maintain the required standards by maintaining awareness 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 and ensuring data protection. The Sr. Records 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, archiving and defensible disposal of documents in support of the Trial Master File (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, retained with high standards and minimal supervision. The Sr. Records Specialist may be called upon to act as archivist for the Global TMF records. during an Inspection or audit.**Essential Functions of the job:**+ Continually improve and contribute to processes within Records 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.+ Assist in drafting and updating Standard Operating Procedures (SOPs) Work Instructions and other controlled documents for job function within Records 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 in yearly testing of the TMF processes and documents to ensure successful audits and inspections.+ Work with functional stakeholders and external third parties as needed to meet internal and external requests.+ Assist and train others on Global Records processes to classify, store, retrieve, refile, retain, archive and destroy records and information.+ Work to complete assigned project tasks and deliverables.+ Troubleshoot issues and bring them to completion, escalating as needed to ensure timely resolution.**Education Required:**+ High school degree with 5+ years of experience in Life Sciences Records Management and/orTrial Master File Management or a college degree in Life Sciences, Records Management methodology, Scientific Library or Library and Information Sciences with 2+ years of experience in Life Sciences Records Management, especially Trial Master File Management.**Skills/Other Qualifications:**+ Experience of 4+ years in the pharmaceutical industry+ Experience 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, including retention requirements and systems utilized in records management and Trial Master File Management in the pharmaceutical industry.+ 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 helpful.+ Ability to lift, drag or carry boxes weighing up to 40 lbs./18 kg.**Travel:** 10%-15%**Competencies:**Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Detailed, customer-oriented and self-motivated focus.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.Project Management - Communicates changes and progress; Completes projects on time and budget.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.

Keywords: BeiGene, Lansing , Senior Document Specialist, Global Records, Other , Lansing, Michigan

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