Department: Regulatory Operations
Reports To (Position): Director of Regulatory Operations
The Technical Editor is responsible for the oversight, management, and coordination of all formatting and submission-ready document preparation for regulatory documents to ensure conformity to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and the eCTD module sections of INDs, NDAs, MAAs and other regulatory submission documents.
Essential Duties/ Responsibilities
- Works effectively with Regulatory Submission Teams to produce high-quality, submission-ready documents under strict timelines, and ensures consistency between related documents
- Responsible for performing a quality check of regulatory documents before approval
- Proofread documents for formatting errors, hyperlink functionality, and conformance to local and internal document submission standards
- Manage timelines and communicate with Document Authors and Regulatory Submission Teams to maintain awareness of expectations, milestones, and deliverables
- Format documents and PDFs written within BeiGene, as well as those authored externally
- Ensure compliance with BeiGene conventions, processes, and applicable regulatory guidelines
- Assist in the establishment and maintenance of department style guides, templates, and essential process guidelines (eg, table and figure format, master reference lists, master abbreviations lists)
- Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Technical Editing Activities
- May manage and men
- Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings.
- Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate.
- Manage vendor relationships including required resources, issue resolution and contract negotiation.
Core Competencies, Knowledge and Skill Requirements:
- Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
- Management experience is preferred.
- Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required
- Strategic thinking is required, with a focus on process improvement and optimization.
- Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
- Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
- Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
- Familiarity with pharmaceutical development and global Regulatory submissions is required.
- Organized with systematic approach to prioritization
- Process orientated to achieve the business objective
- Ability to learn new technologies quickly
- Ability to ensure reviewed documents comply with company and/or industry style guides and templates
- Ability to provide technical editing training (eg, Word) both within and outside of Regulatory Operations, a bonus.
- BA/BS degree; preferably in English, communications, journalism or the life sciences
- least 5 years of relevant industry experience in Regulatory Operations as a publisher, Document Processing, Technical Editor or Word Processor