Director, Medical Writing & Medical Science - 再鼎医药

公司简介

再鼎医药

"鼎力创新，再泽生命"

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所有在招职位

所属团队

Global Research and Development

2个职位在招

职位属性

招聘类型：社招
工作性质：全职
同步至：海外网站&国内网站

职位描述

Work with the Head of MW&MS to continuously improve the quality and efficiency of the MW&MS group by training, optimizing and implementing SOPs/working instructions/templates, and improving project/time management and team communications skills.
Work closely with relevant project team members and function leads to develop resourcing strategies and implement new best practices in clinical/regulatory documents development, and train and develop less experienced writers within the group.
Collaborate with key project team stakeholders and in-house and contract medical writers, plan and prepare clinical and regulatory documents necessary for all phases of drug development by organizing, analyzing, interpreting, and reporting clinical and statistical data. Such documents include but are not limited to clinical study protocols, investigator’s brochures, clinical study reports, patient safety narratives, briefing documents, IND and NDA/BLA/MAA clinical summary and overview sections, and regulatory query responses.
Collaborate with key internal project team members and external stakeholders (eg, investigators, key opinion leaders) to develop high-quality abstracts for congress submissions, posters and slide decks for conference presentations, and manuscripts for publication in international peer-reviewed journals.
Act as a senior reviewer and final quality guarantor of critical clinical, submission, and medical communications documents written by China-based medical writers before sending these documents to external reviews by Zai Lab’s business partners, KOLs, international regulatory agencies, such as US FDA and EMA, and international peer-reviewed medical journals.
Coordinate and lead document roundtables, reviews, approvals, quality control and other document content/format issues and overall questions during documents authoring process.
Resource planning for the US MW&MS team, apply innovative methods when in-house resources are limited.
Provide substantive advice on strategy, regulations and industry best practices to cross-functional teams.
Participate in team meetings to assure cross-functional coordination and alignment to regulatory strategies.
Create procedures that drive consistency in processes and deliverables.
Review and update style guide to ensure consistency across documents.
Other responsibilities as assigned.

任职条件

Minimum BS/BA in life sciences. Advanced degree preferred
At least 15 years of experience in writing clinical regulatory documents; writing expertise preferably includes the oncology therapeutic areas; familiarity with the immunology, Neuroscience, and anti-infective TAs is a plus
Proven superb leadership skills in a multi-cultural environment
Experience and knowledge in the preparation of documents supporting US/EU regulatory submissions
Experience and knowledge in the preparation of abstracts, posters, slide decks, and primary and secondary manuscripts for publication in international peer-reviewed medical journals
Ability to understand and interpret clinical and scientific data
Knowledge and understanding of applicable US and global regulations and guidance
Outstanding organizational skills
Excellent verbal and written communication skills
Outstanding interpersonal skills and the ability to work effectively with a variety of personnel including contract medical writers; ability to influence to create positive outcomes
Experiences in developing processes and standards to ensure high quality and compliance of clinical documents
Knowledge of eCTD content/format requirements
Familiar with document authoring in ICH-compliant templates
Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat

职位要求

学历要求：本科

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