Clinical Regulatory Writing Manager (Associate Director)
About The Position
Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca is where innovation meets collaboration. We harness diverse knowledge to move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing drug development strategy at all levels. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your professional growth is passionately supported here, with opportunities to work on projects at all stages of development. Ready to make an impact? Apply now and be part of our dynamic team! 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.
Requirements
- BS Life Sciences degree in an appropriate discipline.
- Significant (7+ yrs) medical writing experience in the pharmaceutical industry or CRO.
- Ability to advise and lead communication projects.
- Understand drug development and communication process from development, launch through life cycle management.
- In-depth knowledge of the technical and regulatory requirements related to the role.
Nice To Haves
- Advanced degree in a scientific discipline (Ph.D.)
Responsibilities
- Independently manage clinical regulatory writing activities across a complex portfolio of work.
- Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met.
- Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.
- Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.
- Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.
- Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements.
- Demonstrate strategic thinking and review capabilities.
- Collaborate proactively 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.
Benefits
- Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
- Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
