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Document Specialist

Company: BeiGene, Ltd. APAC
Location: San Mateo
Posted on: November 16, 2021

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.

  • This position is a contract to FTE. Candidates in the SF Bay Area are preferred, but remote FTE positions to be considered after initial contractor period. General Description: The Document Specialist, Medical Writing will support/assist in the writing, editing, formatting and overall development of clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and clinical sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents. Essential Functions of the job:
    • Works effectively within the Global Medical Writing department and with cross-functional groups to assist in the development of high-quality, scientifically accurate documents under strict timelines, and helps to ensure consistency between related documents
    • Responsible for ensuring that assigned documents undergo Quality Control reviews and/or Quality Assurance audits before approval, and that documents are routed correctly through the appropriate review and approval cycles (eg Rest of World filing documents)
    • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables (eg, track the collection of clinical study report components from responsible functions - body, synopsis, safety narratives, appendices, TFLs)
    • Review and edit documents, including those authored by others both internally and externally
    • Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)
    • Ensure clinical documents adhere to BeiGene standards and regulatory guidelines Qualifications: Knowledge and Skills
      • Demonstrated ability to communicate and write English clearly, concisely, and effectively
      • Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete highquality documents according to tight timelines and shifting priorities/demands
      • Independently motivated with good problem-solving ability; a fast learner (grasps new ideas and concepts quickly)
      • Excellent interpersonal skills; a team player
      • Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
      • Strong project management skills
      • An understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines is a plus
      • The technical/scientific ability to critically analyze, synthesize, and present complex information in wellconstructed documents
      • Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology is a plus
      • Ability to comply with company and/or industry style guides and templates
      • Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy Supervisory Responsibilities:
        • None Education Required: At a minimum, a BA/BS degree; Master's/PhD/PharmD in life sciences preferred. At least 1 year of health or science related work experience Computer Skills:
          • Technical expertise in Microsoft Word, Adobe Acrobat; proficiency in Microsoft Outlook, Excel and Powerpoint; experience using electronic document management systems is a plus Competencies: Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. 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, non-disqualifying physical or mental 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, Ltd. APAC, San Mateo , Document Specialist, Other , San Mateo, California

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