高级医学撰写师 & 证据分析师
Senior Medical Writer & Evidence Analyst
Catalyst Clinical Research 通过 Catalyst Oncology（全服务肿瘤 CRO）以及 Catalyst Flex 提供多治疗领域全球功能和 CRO 服务，为生物制药和生物技术行业提供定制化解决方案。公司以客户为中心的灵活服务模式、创新技术、专家团队和全球布局推动临床研究。访问 CatalystCR.com
根据高质量标准（内部和外部）独立或与高级医学撰稿人一起撰写和审核监管及其他医学写作交付物，并在预期时间内完成。根据需要支持其他撰稿人撰写论文、幻灯片集、摘要、海报及其他技术商业文档。
职位职责/责任：
- 撰写和审核患者叙事、CSRs、方案、IB 及其他监管提交文件（不包括 CTD 模块），适用于美国 FDA、EMEA 和世界其他地区。
- 独立撰写和审核论文、摘要、海报、证据综合项目及其他技术商业文档。
- 根据可用来源的事实撰写符合质量标准（包括语法和编辑要求）的交付物。
- 遵循所有内部和客户流程，遵守各种 ICH / 监管指南和其他行业最佳实践（例如 GPP）。
- 执行质量控制（QC、科学审查和/或上述交付物的校对）。
- 展现灵活性，根据客户需求和/或治疗领域要求，在不同领域内调整时间安排和写作风格。
- 支持部门整体的审计准备。参与 SOP、操作指南和其他文档的开发。
- 支持个人和部门的发展目标，以满足更大的业务需求。
教育背景：
药学博士（PharmD）、硕士（M. Pharm）、博士（PhD）、医学博士（MD）、生命科学/医学/医学辅助领域的研究生学位
经验：
至少 3-5 年医学写作经验或具有证明的学术标准的写作才能。对药物开发和医疗器械领域的行业标准及全球趋势有基本了解。熟练使用 MS Office 及其他用于撰写和数据处理/解读的软件。对自动化平台有一定的理解和使用能力
所需认证：
相关认证优先，但非必需
- 熟练使用 Microsoft Office 套件。中高级水平
查看英文原文
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
To author, review regulatory & other medical writing deliverables
independently or with other Sr Medical Writer as per high-quality standards (internal & external) and within expected timelines. Support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
Position Responsibilities/
Accountabilities:
- Authoring & review of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents (excluding CTD modules) for US FDA, EMEA and rest of the world.
- Independent authoring and review of manuscripts, abstracts, posters, evidence synthesis projects and other techno-commercial documents as needed.
- Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements).
- Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices (e.g. GPP).
- Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables.
- Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
- Support audit readiness of the department overall. Contribute to development of the SOPs, work-instructions and other documentation.
- Support individual and department development goals for larger business needs.
Education:
PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical
Experience:
At least 3-5 years of experience in medical writing or flair for writing with proven academic standards. Fair understanding of industry standards and global trends in drug development and medical device domains. Highly proficient in MS Office and other software for authoring and data handling/interpretation. Basic understanding and comfort for use of automation platforms
Required Certifications: Relevant certification is preferable but not
mandatory
- Proficient with Microsoft Office Suite. Mid to Advance level expertise for MS WORD features.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to work independently and as a member of various teams and committees.
- Good judgement with the ability to make timely and sound decisions
Originally posted on Himalayas