高级经理，医学写作
Sr. Manager, Medical Writing
职位名称：高级医学写作经理
简介：此职位将管理医学写作团队，并为医学写作客户项目提供咨询和撰写科学、教育、研究和监管文件。将复杂概念和医学术语分解，并根据特定目标受众的理解水平进行撰写。带领团队并管理项目，按时交付高质量的文件，并在部门预算内完成。
具体工作职责：
- 提供医学写作团队的领导和管理。
- 领导项目并准备1期至4期以及上市后监管文件，包括：临床方案和研究报告、研究摘要、IND、NDA和MAA提交文件、安全叙述、登记和观察性研究方案和报告、风险评估与缓解策略（REMS）评估报告、知识、态度和行为调查（KABS）报告，以及用于发表的摘要/论文。
- 确保根据标准操作规程（SOP）对出版物进行同行评审和质量控制。
- 参与UBC和客户项目团队，进行项目规划和时间表制定。
- 与其他UBC部门如SERRM、数据管理、编程、生物统计、质量保证和项目管理协调/咨询医学写作项目。
- 领导制定和审查部门标准操作规程（SOP），以提高流程效率和质量。
- 参与信息请求（RFI）和提案请求（RFP），以获取业务发展机会。
监督职责：
医学写作团队（4-10名资源）
所需技能和资格：
- 生物科学硕士或博士学位，或同等学历
- 10-15年经验，其中至少8年在制药/CRO行业从事医学监管写作或同等岗位
- 在多个治疗领域和临床研究阶段有广泛经验
- 有医学写作团队的领导经验
- 高级文字处理技能（Microsoft Word）和高级Adobe Pro技能
- 熟悉不同的文档管理系统
- 熟悉医学术语和临床试验流程
- 熟悉REMS和KAB监管项目者优先
- 能够解读临床数据，具备强大的分析能力，并能跨部门沟通
查看英文原文
Job Title:Sr. Manager Medical Writing
Brief Description: This position will manage team of medical writers and consult on and compose scientific, educational, research and regulatory documents for Medical Writing client projects. Break down complex concepts and medical terminology and write for the level of understanding for the specific target audience. Lead teams and manage projects to deliver quality documents on time with excellent quality and within department budget.
Specific job duties:
- Provide leadership and management of Medical Writing group.
- Lead programs and prepare Phase 1 through IV and post marketing regulatory documents including: clinical protocols and study reports, study synopses, IND, NDA and MAA submission documents, safety narratives, registry and observational study protocols and reports, risk evaluation and mitigation strategy (REMS) assessment reports, knowledge, attitude, and behavior surveys (KABS) reports, and abstracts/manuscripts for publication.
- Ensure peer review and QC of regulatory documents for publishing according to standard operating procedures (SOPs).
- Participate in UBC and client project teams for project planning and development of timelines.
- Coordinate/consult with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects.
- Lead preparation and review of departmental standard operating procedures (SOPs) to improve efficiencies and quality of processes.
- Participate in requests for information (RFIs) and requests for proposals (RFPs) for business development opportunities.
Supervisory Responsibility:
Team of medical writers (between 4-10 resources)
Desired Skills and Qualifications:
- Master's or doctorate degree in biological sciences or equivalent
- 10-15 years of experience with at least 8 years’ experience in medical regulatory writing or equivalent within the pharmaceutical/CRO industry
- Wide breadth of experience in multiple therapeutics areas and phases of clinical studies
- Leadership experience of a medical writing team
- Advanced word processing skills (Microsoft Word) and advanced Adobe Pro skills
- Familiarity with different document management systems
- Knowledge of medical terminology and understanding of the clinical trial process
- Knowledge of REMS and KAB regulatory programs preferred
- Ability to interpret clinical data and strong analytical skills and communicate to cross-functional teams
- Strong leadership and organizational skills
- Attention to detail/high degree of accuracy
- Strong communication and interpersonal skills
Originally posted on Himalayas