Associate Director, R&I Clinical Regulatory Writing (CReW)
AstraZeneca
Summary
As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice, and continuously advocates for quality and efficiency. The Associate Director also authors strategic clinical-regulatory documents and provides critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery.
Job description
What You Will Do
- Independently manage clinical regulatory writing activities across a portfolio of work.
- Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
- Drive the development of the clinical Submission Communication Strategy.
- 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 information requirements.
- Be a strategic thinker and demonstrate strategic review capabilities.
- Proactively collaborate with other functions at the program level.
- Support the development of others in Clinical Regulatory Writing.
- Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the Clinical Regulatory Writing function on drug and non-drug projects, as required.
Minimum Qualifications
- A Bachelor's degree
- At least 5 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment.
- Experience leading submission authoring and authoring submission level documents.
- Understanding of the drug development process from development through life-cycle management.
- Experience in working within, and contributing to, large, diverse, matrix teams.
- Excellent verbal and written communication skills in English.
- In depth knowledge of the technical and regulatory requirements related to the role.
- Flexibility in adapting to changing circumstances and latest information.
Desirable Qualifications
Advanced degree in a scientific discipline (Ph.D.).
Requirements
- Bachelor's degree
- At least 5 years of experience in medical/regulatory writing in pharmaceutical/biotech industry or CRO
- Experience leading submission authoring and authoring submission level documents
- Understanding of drug development process from development through life-cycle management
- Experience working within large, diverse, matrix teams
- Excellent verbal and written communication skills in English
- In-depth knowledge of technical and regulatory requirements related to the role
- Flexibility in adapting to changing circumstances and latest information
Benefits
- 401(k) plan
- Paid vacation
- Paid holidays
- Paid leaves
- Medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
- Short-term incentive bonus
- Equity-based long-term incentive program
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.