The Director of Medical Writing is a leadership role that will be responsible for developing and implementing medical writing strategies, operational plans, and innovative solutions for all medical writing activities across OPDC. He/she will lead high performing in-house and outsourced medical writing teams in the delivery of high-quality regulatory writing services in accordance with applicable regulatory regulations. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will apply knowledge and make recommendations of best practices to maximize the value of medical writing services and establish and / or oversee key contractual and business relationships with outsourced vendors as needed. Additional responsibilities include developing and managing interpersonal relationships to influence decisions of leaders both within and outside of OPDC, directing the operational implementation of the medical writing department responsibilities. The Director, Medical Writing will identify ways to increase project efficiency, quality and the timely achievement of deliverables; monitor consistency across teams in multiple therapeutic areas, and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide. He/she will evaluate the need to develop and /or enhance SOPs, business guidances, and work processes. • Proactively manages and oversees medical writing activities across therapeutic areas as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.• Contributes to therapeutic project teams as the medical writing expert for all regulatory submission documents. Acts as a cross-functional liaison both internally and externally to manage document preparation processes.• Authors/edits regulatory submission documents, or reviews deliverables produced by team with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to clinical study reports, Investigator’s Brochures [IBs], annual reports, briefing packages, and integrated data summary reports).• Manages and provides mentorship of Medical Writing Staff.• Establishes and standardizes Medical Writing practices/systems/tools to support OPDC clinical studies in order to meet company goals and objectives. Assures that standardized practices are implemented and maintained across all therapeutic areas.• Leads medical writing strategy review and development.• Creates and implements project writing plans.• Supervises medical writers, managers, and contract writers as needed. Directs resource planning, budgeting, and restructuring to meet project and organizational needs and objectives.• Oversee creation and maintenance of templates for reports and patient narratives, and style guide.• Focuses on recognizing efficiencies identified through process improvements and implements them.• Engages with internal stakeholders to assess/understand business priorities and ensures medical writing continue deliver value to the business.• Ensures vendors of medical writing activities meet OPDC quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations. Modify and update SOPs and WPs and supporting processes and documents as appropriate.• Benchmarks with industry peers and across other industries to establish and update best practices medical writing.• Ensure appropriate communication and involvement across functions and therapeutic areas to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies worldwide. • Provides training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.• Reviews new ICH and FDA guidelines regarding medical writing, evaluates their impact on the organization and determines if any procedural changes are needed.