Clinical Publishing Lead
4 weeks ago
At ScaleneWorks, we are seeking a highly skilled Clinical Publishing Lead - Associate Director to join our team. This role will be responsible for providing leadership to the Clinical Publishing team, aligning capabilities and priorities to business and operational needs of the organization.
Key Responsibilities:
- Provide oversight, manage, develop and optimize resources and operational activities.
- Ensure functional deliverables meet technical & procedural compliance with business and regulatory requirements on standards, formats, systems and timeliness.
- Establish a high performing and collaborative service model with optimum utilization of available capabilities.
- Provide strategic and scientific leadership to the organization on the matters of document quality and technical compliance.
- Manage efficient out-contractor relationships to ensure resources to address workload beyond FTE capabilities.
- Contribute to the development and implementation of technical quality standards, standard operating procedures (SOP)s/WKIs, creating efficiency improvements, system automation and communication and training activities.
Requirements:
- Bachelors or Masters in Life Sciences/PhD educated, or equivalent.
- Minimum 10 years' experience in clinical regulatory writing, experience in the pharmaceutical industry, including demonstration of leadership.
Skills:
- Strategic thinking and ability to execute the strategy.
- Demonstrate experience in multicultural settings.
- Leadership and management skills with the ability to manage simultaneous priorities, changing deadlines, and limited resources required.
- Positive attitude, quality focused, collaborative and proactive approach.
- Excellent organizational & communication skills.
- Decisive and capable of influencing individuals and managing teams effectively.
- Strong commitment to internal/external customer responsiveness.
- Thorough and current understanding of FDA, ICH and other appropriate regulations pertaining to regulatory and technical requirements for electronic documents and all types of submission dossiers (format and structure), public registries, technical guidance & legal obligations.
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