We are now recruiting a Senior Director Clinical Regulatory Writing (CReW) to lead the Late Respiratory and Immunology (Late R&I;) CReW teams. The role can be placed in and will report into the Executive Director, Late R&I;. Our Organization follows a hybrid work structure where employees are required to be onsite 3 days a week.
Location : Gaithersburg, Waltham, Gothenburg, Bangalore, and Barcelona
The Clinical Regulatory Writing teams provide 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.
CReW supports the Company's core therapeutic areas in all phases of clinical development. The vision is to be an industry-leading organization driving crucial communication excellence to achieve successful submissions and approvals.
The Senior Director Clinical Regulatory Writing Head will be overall accountable for the provision of expert clinical regulatory writing leadership for programs and activities within Early and Late for the respective TA. In addition, this role will shape the respective TA-specific Clinical Regulatory Writing group by providing strategic direction based on current and future needs, building internal capability, developing and managing vendor relationships, driving digitalization initiatives, and encouraging collaborations with team members and functional counterparts.
You are a proactive leader who understands the imperatives of the respective TA and acts accordingly with a sense of urgency and innovative thinking. In this role, you will act as a line manager, being advocates for your team and creating an engaged and productive environment to thrive.
Accountabilities will include:
Overall accountable for the provision of expert clinical regulatory writing leadership for programs and activities within Early and Late programs within the respective TA.
Ensure thorough engagement with the cross-TA CReW leadership team, the allocation of resources that aligns with strategic prioritization of the respective TAs.
Be a leader within the disease area or drug programs. Actively collaborate with TA strategy leaders to translate portfolio/product direction (e.g., drug programs with multiple indications/combinations) into a strategic vision (i.e., Submission Communication Strategy) for the CReW team.
Set clear direction while advising others and develop innovative solutions in highly complex situations.
Determine and establish group structure in consultation with other TA CReW Heads to meet the business needs of Clinical Regulatory Writing.
Coach, mentor, develop and lead therapeutically aligned staff and identify skill development opportunities for direct reports, together with appropriate succession planning.
Manage budget and productivity targets/metrics for therapeutically aligned staff and programs.
Grow and maintain internal and external relationships with collaborators.
Monitor industry trends and identify future opportunities to support CReW and R&D.
Maintain scientific and technical knowledge to bring transformational opportunities to the CReW functions.
Key relationships in role include internally: CReW TA Heads (Oncology, BioPharma) and Executive Director CReW CVRM and X-TA CReW, Extended network of senior leaders from collaborating functions, relevant TA Business Partners (finance, HR, and Legal) as well as external professional and regulatory organizations and service providers.
To ensure continuous skill area development additional accountabilities include:
Contributing to the outsourcing strategy and ensure appropriate vendor engagement to meet the needs of the respective therapeutic area. Accountable for the execution of functional vendor utilization strategies that optimize time/quality and cost of document deliverables.
Therapy area CReW capability development, training, and process improvement.
Contributing to CReW digitalization and other initiatives to achieve the R&D business objectives.
Therapy area CReW strategic workforce planning including exploration and continued build of new geographies.
Therapy area operational metrics.
Minimum Qualifications:
Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment across global projects and regions.
Broad cross-functional understanding of the drug development process from scientific, technical, and business perspectives.
Established experience of leading large, diverse organizations. Proven experience of establishing dedicated teams, attracting top talent, and developing capabilities in others.
Proven ability to work with vendors to deliver to budget, quality, time, and cost.
Conceptual and strategic problem solver with strong networking and influencing skills.
A relationship builder who can work effectively in matrix organizations.
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