Senior Scientist I/II, Clinical Regulatory Writing
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Beijing • 🇨🇳 China
Visit company websiteJob Level
Senior
About the role
- Working as part of a clinical delivery team, to provide communication and writing support at the document development level for China NDA/sNDA/IND.
- Support creation of Clinical Submission Strategy.
- Facilitate and support the development of key storyboard for a submission, in collaboration with team members.
- Build and deliver clinical-regulatory submissions and defense.
- Function as the document lead to deliver clinical dossiers to a submission.
- Ensure alignment of clinical submission documents with the proposed prescribing information.
- Be a member of a cross-functional submission team.
- Author documents that facilitate efficient evaluation and approval by health authorities.
- Author complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees), with close senior guidance.
Requirements
- A Bachelor (BS/BPharm) degree in Life Sciences/Pharmacy/Pharmacology is required
- Minimum of two years' experience within the pharmaceutical/biotechnological industry/CRO
- Good working knowledge of the clinical drug development process with experience in integrating information from phases of clinical development into clinical-regulatory documents/submissions
- Good knowledge of relevant and current regulatory guidelines relating to regulatory communications.
- Good communication skills, both written and oral.
- Project and Self-Management Skills – Ability to cope work and get things done and deliver independently
- Collaboration skills, good negotiation and interpersonal skills, high ethical standards.
- Strong scientific knowledge. Ability to integrate information from phases of drug development into filings.
Benefits
- AstraZeneca embraces diversity and equality of opportunity.
- We are committed to building an inclusive and diverse team representing all backgrounds.
- We believe that the more inclusive we are, the better our work will be.
- We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
- We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment).
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical submission strategyclinical regulatory submissionsdocument developmentclinical dossiersclinical overviewsregulatory communicationsclinical drug development processintegrating information from clinical development phasesauthoring complex documentsevaluation and approval by health authorities
Soft skills
communication skillsproject managementself-managementcollaboration skillsnegotiation skillsinterpersonal skillsethical standardsability to work independentlywriting skillsteam collaboration
Certifications
Bachelor's degree in Life SciencesBachelor's degree in PharmacyBachelor's degree in Pharmacology