JOB TITLE :Associate Director-Clinical Regulatory Writing
CAREER LEVEL: E
Lead the way for a new breed of solutions-oriented Regulators.
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking.
Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development.
Be part of the team where you are empowered to follow the science.
Be part of the solution, turning our drug development strategies into reality.
Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need, and healthcare professionals.
About AstraZeneca
At AstraZeneca we're dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.
There's no better place to make a difference to medicine, patients, and society.
An inclusive culture that champions diversity and collaboration.
Always committed to lifelong learning, growth, and development.
About the team
We are a diverse and open-minded team harnessing our different skills and experiences.
As a Regulatory function we use our capabilities to accelerate discovery and development.
Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
About the role
Role holders provide strategic leadership and communications expertise to clinical drug programs.
They author clinical-regulatory documents and provide critical review to achieve high quality standards.
They represent the skill on drug and non-drug projects.
Typical Accountabilities
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices.
We support the Company's core therapeutic areas in all phases of clinical development.
Our vision is to be an industry-leading organization driving critical communication excellence to achieve successful submissions and approvals.
The Clinical Regulatory Writing Associate Director is expected to:
Independently handle clinical regulatory writing activities across a complex portfolio of work.
Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practices are applied.
As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practices, and continuously advocate for quality and efficiency.
When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.
Drive the clinical interpretation of complex data and information and condense it into clear, concise, and accurate messages that address customer information requirements.
Be a strategic problem solver and demonstrate strategic review capabilities.
Proactively collaborate with other functions at the program level.
Support the development of Clinical Regulatory Writing Managers.
Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.
Education, Qualifications, Skills and Experience
Essential
Life Sciences degree in an appropriate field.
Significant medical writing experience in the pharmaceutical industry or CRO.
Ability to advise and lead communication projects.
Understand drug development and communication processes from development, launch through life cycle management.
In-depth knowledge of the technical and regulatory requirements related to the role.
Desirable
Advanced degree in a scientific discipline (Ph.D.).
WHY JOIN US?
We believe there's always a better way of doing things.
Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things, and sharing new proposals.
Our advanced approach to Regulatory means we are leading the field.
We get to work closely with drug development to influence early on and continue to make valuable contributions throughout.
SO, WHAT'S NEXT?
Are you already envisioning yourself joining our team?
Good, because we'd love to hear from you!
Click the link to apply and we'll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
OurSocial Media, Follow AstraZeneca on LinkedInhere.
We are an equal opportunity employer and value diversity at our company.
We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.#J-18808-Ljbffr