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 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 optimisation 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.
The Clinical Regulatory Writing Program Lead is expected to:
- 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.
Education, Qualifications, Skills and Experience
Essential
- Life Sciences degree in an appropriate discipline.
- Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment in positions with increasing levels of responsibility. Includes proficiency at authoring/editing and managing the writing/review of multiple types of clinical regulatory documents and submissions and extensive knowledge and experience relevant to multiple therapeutic areas, disease areas, and technical disciplines.
- Broad cross-functional understanding of the drug development process from scientific, technical and business perspectives.
- In-depth knowledge of the technical and regulatory requirements related to the role.
• Ability to effectively communicate with stakeholders within AstraZeneca and beyond. • Is a conceptual and strategic thinker 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.
- Established supervisory experience managing multiple direct reports or contract staff in a medical writing group or equivalent. Includes hiring, training, leading, and mentoring staff, setting goals within the function, and managing performance issues. Experienced in developing and overseeing and resource allocation
