Job title: Manager Clinical Regulatory Writing
Company: AstraZeneca
Job description: JOB TITLE : MANAGER CLINICAL REGULATORY WRITING
CAREER LEVEL: D
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 communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level. They contribute to improvement 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 essential communication excellence to achieve successful submissions and approvals.
The Manager II, Clinical Regulatory Writing is expected to:
With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents such as CSPs, CSRs, IBs, BDs, Module 2.7 submission documents, briefing documents, pediatric plans, regulatory response, and specific documents supporting established brands.
Ensure that relevant regulatory, technical and quality standards are achieved, and that relevant processes and standard methodology are applied.
Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
Drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements.
Provide critical review of documents for correctness, clarity, completeness and compliance.
Proactively collaborative with other functions during document development, including, as needed, with external service providers/contractors.
As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required.
Work independently but with the guidance and support of more senior members of the group
Education, Qualifications, Skills and Experience
Essential
Life Sciences degree in an appropriate discipline.
Experience in medical communications.
Strong communication and leadership skills.
Knowledge of the technical and regulatory requirements related to the role.
Desirable
Advanced degree in a scientific discipline (Ph.D).
Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.
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 add value 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?
Our Social Media, Follow AstraZeneca on LinkedIn
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.
Date Posted 21-Mar-2022
Closing Date
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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Tue, 22 Mar 2022 23:20:45 GMT
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