Senior Scientist I/II, Clinical Regulatory Writing at AstraZeneca

Daxing District, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

0.0

Posted On

07 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Regulatory Writing, Project Management, Communication Skills, Self-Management Skills, Collaboration Skills, Negotiation Skills, Scientific Knowledge, Problem Solving, Conflict Resolution, Leadership, Drug Development Knowledge, Regulatory Guidelines, Clinical Submission Strategy, Document Development, Cross-Functional Teamwork, Agility, Flexibility

Industry

Pharmaceutical Manufacturing

Description

RESPONSIBILITIES: • 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 will 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 (eg, 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 REQUIRMENTS: • 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. Date Posted 07-12月-2025 Closing Date 27-2月-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Senior Scientist will provide communication and writing support for clinical regulatory submissions, including the development of key storyboards and clinical dossiers. They will also ensure alignment of submission documents with prescribing information and contribute to team excellence.