出海雷达

Medical Writer

市场运营限定地区(需当地身份)
公司Quanticate
薪资未公开
工作地点India
地域资格限定地区(需当地身份)
时区要求日间重叠约 6 小时,基本正常作息
用工类型Contractor
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 India 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。
关于本页中文:职位描述由本机离线模型翻译,属机器翻译,供快速判断用;正式沟通与投递请以英文原文为准。官方翻译通道恢复后会自动重译升级。

加入我们的医学写作团队,并在提供高质量的科学和监管文件中发挥关键作用,支持全球临床开发计划。作为医疗作家 (顾问),你将领导和贡献各种医疗写作项目,与跨职能团队和客户合作以确保交付准确,合规和有影响力的文档。你还将担任专家主题,为同事提供指导,并在整个功能中支持持续改进。· 撰写,审查和质量检查一系列监管和科学文件,包括临床研究报告和其他医学书面成果。·确保所有文件都准确反映出源数据,满足监管要求,并遵守公司和客户标准。·管理文档审查周期,解决审稿人意见,协调来自多方利益相关者的反。· 在需要时提供编辑支持,校正和质量控制评估。· 支持文档发布活动和提交现成的结果编译。项目领导力与交付。·同时管理多项写作项目,确保在达成的时间表和预算内完成。· 使用项目管理工具追踪项目里程碑,风险和进展。·与项目团队,审查人员和主题专家密切合作以确保有效执行项目。·保持准确的项目记录,包括时间报告和跟踪指标。客户伙伴关系和商业支持。·作为分配项目上的客户联系点。·通过专业沟通和高质量的交付建立和维护强的客户关系。· 支持建议的开发,报价辩护会议和业务发展活动如需要。· 贡献客户满意度倡议并提供反以支持持续服务改进。导师与知识分享。· 为年轻医学作家和团队成员提供培训,指导和导师。· 促进组织中知识共享和最佳实践。· 支持流程改善举措,帮助推动医疗写作功能内的创新。监管和行业专业知识 · 与不断变化的监管要求,GCP 标准和科学通信准则保持最新状态。· 监管性分享。

查看英文原文

Join our Medical Writing team and play a key role in delivering high-quality scientific and regulatory documents that support clinical development programmes worldwide.
As a Medical Writer (Consultant), you will lead and contribute to a variety of medical writing projects, collaborating with cross-functional teams and clients to ensure the delivery of accurate, compliant, and impactful documentation. You will also act as a subject matter expert, providing guidance to colleagues and supporting continuous improvement across the function.
What You'll Do
Medical Writing & Document Development

  • Author, review, and quality-check a range of regulatory and scientific documents, including clinical study reports and other medical writing deliverables.
  • Ensure all documents accurately reflect source data, meet regulatory requirements, and comply with company and client standards.
  • Manage document review cycles, resolve reviewer comments, and coordinate feedback from multiple stakeholders.
  • Provide editorial support, proofreading, and quality control reviews where required.
  • Support document publishing activities and compilation of submission-ready deliverables.

Project Leadership & Delivery

  • Manage multiple writing projects simultaneously, ensuring delivery within agreed timelines and budgets.
  • Track project milestones, risks, and progress using project management tools.
  • Collaborate closely with project teams, reviewers, and subject matter experts to ensure efficient project execution.
  • Maintain accurate project records, including time reporting and tracking metrics.

Client Partnership & Business Support

  • Serve as a point of contact for clients on assigned projects.
  • Build and maintain strong client relationships through professional communication and high-quality delivery.
  • Support proposal development, bid defence meetings, and business development activities as required.
  • Contribute to client satisfaction initiatives and provide feedback to support continuous service improvement.

Mentoring & Knowledge Sharing

  • Provide training, guidance, and mentorship to junior Medical Writers and team members.
  • Promote knowledge sharing and best practices across the organisation.
  • Support process improvement initiatives and help drive innovation within the Medical Writing function.

Regulatory & Industry Expertise

  • Stay current with evolving regulatory requirements, GCP standards, and scientific communication guidelines.
  • Share regulatory updates and industry best practices with colleagues and clients.
  • Engage with relevant industry forums and professional networks to maintain expertise and awareness of emerging trends.

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Requirements
What You'll Bring
Qualifications

  • Master's degree in Life Sciences, Medical Sciences, Pharmacy, or a related scientific discipline.
  • A PhD, PharmD, MD, MVSc, or equivalent advanced qualification is desirable.

Experience

  • 4+ years of medical writing experience within the pharmaceutical, biotechnology, CRO, or healthcare sector.
  • Strong experience preparing regulatory and scientific documents.
  • Solid understanding of regulatory requirements and scientific communication guidelines.
  • Experience mentoring or supporting the development of colleagues.
  • Publications in peer-reviewed scientific literature would be advantageous.

Skills & Competencies

  • Exceptional written and verbal communication skills.
  • Ability to translate complex scientific concepts into clear, concise, and audience-appropriate content.
  • Strong attention to detail and commitment to quality.
  • Excellent organisational, project management, and prioritisation skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently while contributing effectively within cross-functional teams.
  • Confident stakeholder management, influencing, and negotiation skills.
  • Proficiency with Microsoft Office and document management systems.
  • Commitment to continuous learning and professional development.

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at .
Benefits

  • Competitive salary
  • Flexible working hours
  • Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
  • Medical Insurance for self and immediate family
  • Gratuity
  • Accidental Coverage
  • Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)

Originally posted on Himalayas

本页面信息整理自 Himalayas,版权归原发布方所有。职位可能随时关闭,投递请以原始页面为准。 本站只做信息聚合展示,不参与招聘流程,也不向求职者收取任何费用。

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