首席医疗撰稿人
PRINCIPAL MEDICAL WRITER
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、专业团队和全球布局推动临床研究的发展。访问 CatalystCR.com
根据高标准（内部和外部）独立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。通过设计和执行稳健的培训计划，支持团队的技术和功能专业知识建设。根据需要，协助其他作者撰写论文、幻灯片集、摘要、海报及其他技术商业文档。
- 撰写和审核 CSRs、方案、IB、简报手册及其他监管提交文件（包括 CTD 模块），适用于美国 FDA、EMEA 及全球其他地区。此外，根据需要参与论文、摘要、海报及其他技术商业文档的撰写。
- 与数据分析师和统计学家合作开展真实世界及其他证据生成项目。
- 根据可用来源的事实撰写科学准确的交付物，并满足质量标准（包括语法和编辑要求）。
- 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。
- 对上述交付物进行质量控制（QC、科学审查和/或校对）。
- 根据客户需求和/或治疗领域要求，在不同领域中展示时间安排和写作风格的灵活性。
- 有效开展客户/KOL 互动、启动会议和电话会议，覆盖不同时区。
- 担任指定客户的项目负责人/交付负责人，负责每个账户的健康合作关系。
- 支持创新举措，包括但不限于自动化和流程改进。
- 为团队开展扎实的培训计划，并支持该领域的思想领导活动。
- 负责部门整体的审计准备情况。指导 SOP、操作说明和其他文档的开发。
- 主动支持业务扩展和部门运营活动，根据需要提供支持。
管理要求/职责：
该职位将有管理职责
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 and review regulatory & other medical writing deliverables independently as per high-quality standards (internal & external) and within expected timelines. Support in building technical & functional expertise within the group by designing & executing robust training programs. Contribute/support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
- Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents (including CTD modules) for US FDA, EMEA and rest of the world. Additionally, contribute to manuscripts, abstracts, posters, other techno-commercial documents as needed.
- Work with data analysts and statisticians on Real world and other evidence generation projects.
- 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.
- 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.
- Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
- Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.
- Support innovation initiatives, including but not limited to automation and process improvement.
- Conduct robust training programs for the team & support thought leadership activities in the domain.
- Responsible for audit readiness of the department overall. Guide development of the SOPs, work-instructions and other documentation.
- Support proactively in business expansion & department operation activities as needed.
Managerial Requirements/ Responsibilities:
Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.
Position Qualification Requirements:
Education:
PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical
Experience:
At least 10- 11 years of experience in medical writing, drug development, clinical research, out of which at least 5 years in core medical writing (regulatory deliverables). Scientific writing (publication/manuscripts etc) experience is desirable but not mandatory.
Required Skills:
- Proficient with Microsoft Office Suite. Advance level expertise for MS WORD features and macro relation functionalities.
- 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.
- 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 judgment with the ability to make timely and sound decisions.
Originally posted on Himalayas