Posted 2 months ago
R&D - CSO - Medical Writer - CD
AI Summary
Regulatory medical writer preparing clinical documents (protocols, study reports, summaries) for China and global submissions, coordinating with cross-functional teams to deliver high-quality documents on time.
About this role
About the job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Our Team:
Medical writing in Sanofi is regulatory medical writing which is used to advance a drug, device, or biologic from clinical studies through regulatory agency approval. China medical writing team is part of global medical writing team, we support the clinical document preparation for both China and global submissions. Our goal is to deliver the documents on time, with good quality and per transparency requirements. Our mission is to lead our activities with innovation and quality to make clinical trial information and drugs available to patient as quickly as possible and contribute to Sanofi business growth.
Main responsibilities:
Writing, summarizing, editing, and reviewing documents, or sections of documents (eg, protocol, clinical study report, summary documents)
Ensuring architecture and content that concisely and effectively transmit strategic information
Coordinating the activities within the group, and those with interfaces in Platform, other Units, or external collaborators, to ensure timely completion of deliverables
Defining and proposing best timelines for the group deliverables, in collaboration with authoring or submission teams
Defining and requesting quality control for the group deliverables
About you
Experience: A 2-4 years’ experience in pharmaceutical industry or publications in the international journals as the first author would be an asset.
Soft skills: Ability to communicate clinical data succinctly, clearly and accurately in writing. Proactive, accountable, details oriented. Interpersonal communication skill and a good team player and good planner.
Technical skills: Professional background suggesting the ability to clearly, accurately, and concisely prepare all types of simple documentation in both English and Chinese, e.g. scientific authorship experience, editorial experience, etc.
Education: A candidate with a scientific degree, preferably PhD, majoring in medicine, pharmacy, or life science related disciplines.
Languages: Proven level of excellent spoken and written English, including understanding of English language usage and also standardized writing styles.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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