Associate Director / Director, Clinical Regulatory Writing (Program Lead)

About the role

AstraZeneca is looking for an Associate Director / Director, Clinical Regulatory Writing (Program Lead) based in Barcelona, working 3 days in the office and 2 days from home. The role provides expert communications leadership across clinical programs, drives collaboration and growth within Clinical Regulatory Writing, and acts as a lead clinical regulatory writer and coach for other leads and writers. It may also involve line management of direct reports.

Key responsibilities

• Provide expert leadership across a group of submissions or programs, overseeing the communication strategy and driving the use of drug and disease-specific knowledge across teams.
• 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, and act as a leader within the disease area or drug programs.
• Lead submission activities when acting as submission lead, authoring clinical submission communication strategies and reviewing key submission documents for consistent messaging.
• Coach and mentor Clinical Regulatory Writers, peer review, remove obstacles and mitigate risks; represent the function on improvement workstreams, business initiatives and external meetings.
• Drive resourcing strategy, interface with medical writing vendors on contracting and oversight of outsourced work, and support recruitment and onboarding.
• In line management: set clear objectives, manage performance development and promotion/succession, support continuous learning, manage risk and issues, and monitor performance, compliance and workload metrics.

Required profile

• Life sciences degree in an appropriate discipline.
• Significant experience in medical/regulatory writing in a pharmaceutical, biotech or CRO environment, with increasing levels of responsibility and knowledge of multiple therapeutic areas.
• Broad understanding of the drug development process and in-depth knowledge of the technical and regulatory requirements of the role.
• Desirable: advanced degree (Ph.D.), established reputation in the business and industry, and supervisory experience managing multiple direct reports or contract staff.

Required skills

• Authoring, editing and managing the writing and review of clinical regulatory documents and submissions.
• Ability to work with vendors to deliver to budget, quality, time and cost.
• Strong networking skills and ability to communicate with stakeholders internally and externally.