Associate Director, Clinical Publishing Lead

2 months ago

Bengaluru, India ScaleneWorks Full time

Job Description:

• Provide leadership to the Clinical Publishing team, to align capabilities and priorities to business and operational needs of the organization (Priorities and resource management)
• Manage, develop, and optimize resources and operational activities to ensure coordination and timely production of deliverables (on-time delivery with quality)
• Promote best practices, continuous improvement, and innovation within the team and across the organization as relevant to foster IPTc (Process simplification, alignment with functions)
• Management oversight to risk to operational and strategic goals, budget, performance and development of capabilities (people development/management, budget)

Key Responsibilities:
Leadership, Operational and Strategy:

• Provide oversight, manage, develop and optimize resources and operational activities (including but not limited to electronic submission requirements, compliance check, publishing, template management, archival in EDMS, submission delivery).
• Ensure functional deliverables meet technical & procedural compliance with business and regulatory requirements on standards (stipulated by GCP, HRAs, Internal etc), formats, systems and timeliness to produce quality functional deliverables. Maintain quality by enforcing and evolving standards; analyzing and resolving problems; identifying trends; recommending system improvements.
• Establish a high performing and collaborative service model with optimum utilization of available capabilities, continuous development of people, processes and systems. Ensure priority conflicts, risk escalation, and that deviations from the plan are resolved to minimize impact on submission dates and other relevant milestones.
• 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.
• Maintain a strong understanding of applicable software, tools, processes and workflows.

People and stakeholder:

• Manage a team of inhouse and external associates involved in clinical publishing, submission delivery, with diverse educational, cultural and professional experience.
• Lead through appropriate delegation, motivation, technical direction, knowledge sharing and reassurance of team discussion and internal problem solving. Accomplish results by communicating job expectations; planning, monitoring, and appraising; coaching, training and counselling employees; developing, coordinating, feedback and enforcing systems, policies, procedures, and productivity standards.
• Develop team members to expand competence and capability through training, setting SMART objectives, appropriate feedback and monitoring to ensure individual growth and team dynamics while meeting organizational and business objectives.
• Serve as a focal point to Clinical Submissions & Technical Compliance Delivery, Interface and matrix align with Medical Writing, Clinical R&D, Clinical operations, GRA and Public disclosure on timelines, priorities, and other expectations (including quality). Agree and manage SLAs, KPIs and appropriate monitoring and escalations.
• Strong understanding and ability to incorporate organizational considerations into strategic and operational decisions.
• Demonstrated track record of quality decision making and creative problem resolution with significant impact on operations, systems, processes, programs/project direction.
• Inspire and encourage a culture of creative thinking to propose new solutions to established and emerging challenges.
• Demonstrating courage to challenge the status quo and implement new radical solutions.

Education Requirements (minimum expected):

• Bachelors or Masters in Life Sciences/PhD educated, or equivalent.

Job Related Experience (minimum requirements):

• Minimum 10 years’ experience in clinical regulatory writing, experience in the pharmaceutical industry, including demonstration of leadership.

Other Job-Related Skills:

• Strategic thinking and ability to execute the strategy.
• Demonstrate experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams).
• Leadership and management skills with the ability to manage simultaneous priorities (task planning), 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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