Overview
Director, Clinical Regulatory Writing (Program Lead) – AstraZeneca
Location: Barcelona, Spain (3 days/week working from the office). 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 strategic communication excellence to achieve successful submissions and approvals.
Clinical Regulatory Writing Program Leads are engaged in multiple, complex, high-priority programs, acting as the lead clinical regulatory writer and as a coach for other leads and clinical regulatory writers. They advocate for the team and create an engaged and productive environment. They may operate across multiple indications within a single drug program or across different drug programs within the therapeutic area.
The Program Lead develops communications strategies to guide these programs, advocates for best practices in document and submission delivery, represents strategic communications in business process optimization, and supports talent growth and development. They may also be line managers, providing coaching, strategic direction, and opportunities at the individual and departmental level.
Responsibilities
* Provide expert leadership across a group of submissions or programs, overseeing the communication strategy.
* Drive the use and sharing of drug- and disease-specific knowledge across program and submission teams through a network of Program Leads.
* Identify commonalities and differences in communication strategy, content, and process across programs and optimize approaches.
* Influence stakeholders at the highest levels to establish best communications practices across a therapeutic area or business unit.
* Lead and advise on drug programs, setting clear direction and developing innovative solutions in highly complex situations.
* Lead submission activities when acting as a submission lead or author key submission documents within a program.
* Review key submission documents for consistency of messaging, as agreed with submission leads.
* Strive for excellence, drive standards, and provide support and training to projects and vendors as required.
* Develop best practices for the Clinical Regulatory Writing organization. Coach and provide strategic guidance to writers, peer review, remove obstacles, and mitigate risks.
* Represent Clinical Regulatory Writing on improvement initiatives and external activities as a subject matter expert.
* Drive resourcing strategy within the area of accountability and interface with medical writing vendors for contracting and external work management.
* Support recruitment and onboarding for new group members.
Line Management
* Communicate objectives to staff and manage performance development, promotions, and succession planning.
* Provide opportunities for continuous learning through project initiatives and regular team and 1:1 discussions.
* Support group risk and issue management and monitor metrics for performance, compliance, and workload.
* Lead recruitment and onboarding activities for new group members.
Essential – Education, Qualifications, Skills and Experience
* Life Sciences degree in an appropriate discipline.
* Significant experience in medical/regulatory writing within pharmaceutical/biotech or CRO environments, with growing responsibilities. Proficiency in authoring/editing and managing multiple clinical regulatory documents and submissions, and broad knowledge across therapeutic areas and technical disciplines.
* Broad cross-functional understanding of the drug development process from scientific, technical, and business perspectives.
* In-depth knowledge of technical and regulatory requirements relevant to the role.
* Effective communication with internal and external stakeholders.
* Conceptual and strategic thinking with strong networking skills.
* Ability to work with vendors to deliver to budget, quality, time, and cost.
Desirable
* Advanced degree in a scientific discipline (Ph.D.).
* Expert reputation within the business and industry.
* Experience supervising multiple direct reports or contract staff in a medical writing group or equivalent, including hiring, training, leading, mentoring, goal-setting, and performance management. Experience in resource allocation.
Date Posted
10-Sept-2025
Closing Date
29-Sept-2025
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.
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