Senior Scientist I/II, Clinical Regulatory Writing Full-time

Clinical Regulatory Submission Specialist

Working as part of a clinical delivery team, to provide communication and writing support at the document development level for China NDA/sNDA/IND, with a good proportion of project work involvement project management.

With senior guidance, 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 (e.g., Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees), with close senior guidance.

Contribute to team excellence building, areas of activities including (but not limited) to:

Contribute to the implementations of AZ best practices and ensure consistency with global Med Comms.

Contribute to best practice learning, sharing and forming.

May act as MC lead for certain projects.

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.

Communication Skills – Good communication skills, both written and oral. Able to apply robust communication processes and standards to ensure the efficient delivery, quality and compliance of clinical regulatory documentation.

Project and Self-Management Skills – Ability to cope work and get things done and deliver independently in common situations. Demonstrate ability to manage non-standard situation, with close senior guidance. Agility and ability to learn to adapt to a changing regulatory and communications environment. Able to be proactive, flexible, and resilient.

People Skills – Collaboration skills, good negotiation and interpersonal skills, high ethical standards. Ability to work well within a cross-functional team in a matrix organization.

Thinking Skills – Strong scientific knowledge. Ability to integrate information from phases of drug development into filings. Good problem and conflict resolution capability, including ability to apply subject expertise and contribute to optimal solutions for team.

Expert Leadership – Willingness to take responsibility to provide constructive feedbacks. Ability to form collaborative working relationship with cross-function team members to deliver to quality, speed and value.

Knowledge of Drug Development – Good knowledge of drug development, regulatory guidelines and reviewers' expectations.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. 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), as well as work authorization and employment eligibility verification requirements.