17 Oct
GlaxoSmithKline
Mississauga
Site Name: Bengaluru Luxor North Tower, Mississauga Milverton Drive
Posted Date: Oct 16 2024
Years of Experience: 10-13 years
Skill Set / Exposure: Electronic submission, Clinical Publishing, eCTD, e-publishing software, Leadership, people development, talent management, budgeting and third party resource management
Work Location: Bengaluru
Mode: Hybrid Mode (3-4 days office)
Job Description:
- Provide leadership to the Clinical Publishing team, to align capabilities and priorities to business and operational needs of the organization.
- Manage, develop and optimize resources and operational activities to ensure coordination and timely production of deliverables.
- Promote best practices,
continuous improvement and innovation within the team and across the organization.
- Management oversight to risk to operational and strategic goals, budget, performance and development of capabilities.
Key Responsibilities:
Leadership, Operational and Strategy:
- Provide oversight, manage, develop and optimize resources and operational activities including 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.
- Establish a high performing and collaborative service model with optimum utilization of available capabilities, continuous development of people, processes and systems.
- Provide strategic and scientific leadership to the organization on 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, SOPs/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 Management:
- Manage a team of inhouse and external associates involved in clinical publishing and submission delivery.
- Lead through appropriate delegation, motivation, technical direction, knowledge sharing and team discussion.
- Develop team members to expand competence and capability through training and feedback.
- Serve as a focal point to Clinical Submissions & Technical Compliance Delivery, interfacing with Medical Writing, Clinical R&D;, Clinical operations,
GRA and Public disclosure.
- Demonstrate a strong understanding and ability to incorporate organizational considerations into strategic and operational decisions.
- Inspire a culture of creative thinking to propose new solutions to challenges.
- Demonstrate courage to challenge the status quo and implement new 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, with experience in the pharmaceutical industry.
Other Job-Related Skills:
- Strategic thinking and ability to execute the strategy.
- Experience in multicultural settings.
- Leadership and management skills with the ability to manage simultaneous priorities.
- 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 understanding of FDA, ICH and other appropriate regulations pertaining to regulatory and technical requirements for electronic documents.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We focus on the science of the immune system and the use of new platform and data technologies,
investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
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▶️ Associate Director, Clinical Publishing Lead
🖊️ GlaxoSmithKline
📍 Mississauga