Director, Clinical Regulatory Writing (Program Lead)

Are you passionate about science and experience within regulatory affairs and drug development? We are now recruiting a Director, Clinical Regulatory Writing (CReW Program Lead).

In this role you will provide expert leadership to the delivery of the CVRM product pipeline through partnering with senior leaders to define and lead the global communications strategy. You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners.

This opportunity is available at our Gaithersburg, MD (USA) location. We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working.

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 often engaged in multiple, complex, and high priority programs simultaneously, acting as the lead clinical regulatory writer themselves and as a coach for other leads (eg, Submission Leads) and Clinical Regulatory Writers, being advocates for the team and creating an engaged and productive environment. Clinical Regulatory Writing Program Leads can operate across multiple indications within a single drug program or across different drug programs within the TA. The Clinical Regulatory Writing Program Lead develops communications strategies to guide these programs while advocating and developing best practices for document and submission delivery, representing strategic communications expertise in business process optimization and improvement initiatives, and supporting the growth and development of talent.

The Clinical Regulatory Writing Program Leads in this role may also be line managers, accountable for coaching and mentoring their direct reports fairly and providing strategic direction and highlighting new opportunities at the individual and departmental level.

What You’ll Do:

• Provide expert leadership across a group of submissions or programs, overseeing the communication strategy.
• Drive the use and exploitation of information by sharing drug and disease-specific knowledge and experience across program and submission teams and through a network of Program Leads.
• Identify commonalities and differences in communication strategy, content and process across multiple programs or submissions, and optimize approaches.
• Influence stakeholders at the highest levels of the organization, eg, to establish best communications practices across a TA or Business Unit.
• Be a leader within the disease area or drug programs. Set clear direction while advising others and develop innovative solutions in highly complex situations (eg, drug programs with multiple indications/combinations).
• Lead submission activities when acting as a submission lead (eg, authoring clinical submission communication strategies) or lead authoring other key documents within a program.
• Review key submission documents across the continuum for consistency of messaging, as agreed with submission leads.
• Be relentless in pursuit of excellence, personally driven to improve standards across the business and provide relevant support and training to projects and vendors, as required.
• Continuously develop best practice for the Clinical Regulatory Writing organization. Actively coach and provide strategic steer to Clinical Regulatory Writers. Peer review, remove obstacles and proactively identify and mitigate risks.
• Represent Clinical Regulatory Writing on various improvement workstreams, business initiatives, and external activities and meetings by acting as a subject matter expert.
• Drive resourcing strategy within area of accountability. Directly interface with medical writing vendors in contracting and overseeing externalized work.
• Support recruitment and onboarding activities for new members of the group.

In Line management Role:

• Clearly communicate company and team objectives to the staff that they line manage.
• Manage performance development process and drive promotion and succession activities.
• Provide staff with opportunities for continuous learning and development through different project and non-project initiatives and through leading regular team and 1:1 discussions.
• Support group with risk and issue management and monitor metrics for performance, compliance, and workload (and react accordingly).
• Drive recruitment and onboarding activities for new members to the group.

Requirements:

• 10 years of active medical writing experience and a Master’s of Science, PhD is strongly preferred
• Thorough understanding of the oncology drug development and knowledge of oncology endpoints is a must
• Clinical interpretation skills, Stakeholder management, Multitasking, High-pressure/high-pace
• IND (Briefing documents, Clinical study protocols, Paediatric investigational plans, Phase 1 and 2 CSR)
• NDA (Phase 3 CSR, Module 2 Summaries)
• Health authority response (HAQ)
• Program management experience required
• Line management experience preferred and expected

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.