Klein Hersh International is hiring: VP, Medical Writing (Regulatory) in Alameda

As a diverse, growing team, everyone our client employees plays a role in advancing their mission through our innovative drug discovery, development and commercialization efforts. The Vice President Regulatory Science Communications is responsible for the functional areas of Scientific/Regulatory Writing, Regulatory Editing, and Regulatory Document Quality Control to ensure the timely preparation and submission of critical regulatory documents such as IND/CTA, NDA/BLA/MAA, regulatory responses, briefing documents, clinical protocols, clinical study reports, investigator brochures, and others across all stages of development. Key Responsibilities: Provides expert leadership for each functional area to ensure the timely preparation, completion, and submission of critical regulatory documents. Builds and maintains an effective team by recruiting and hiring appropriate personnel to execute tasks related to regulatory document development, publishing, and submission. Oversees teams to organize, manage, and execute tasks related to the development of documents, ensuring that timelines and quality standards are met. Helps teams negotiate timelines with key stakeholders for documents intended for regulatory submission. Oversees the identification, hiring, and managing of consultants for peak workload and specialized projects. Actively manages departmental resources and budget to meet strategic goals. Oversees development of standards, procedures, and optimized processes for regulatory document development. Reviews and contributes to content development and critically assesses, interprets, and summarizes data to produce high quality communications. Ensures consistency in documents within and across programs by overseeing the management of messages and developing and maintaining document standards, models, and templates. Oversees the development of appropriate SOPs and work instructions for each functional area within the Regulatory Science Communications group. Identifies continuous improvement opportunities and acts to improve processes. Directly supervises heads of each functional area: Scientific/Regulatory Writing, Regulatory Editing, and Regulatory Document Quality Control. Supervises staff, including hiring, reviewing performance, and recommending salary increases, promotions, transfers, demotions, or terminations. May support and direct work of contract scientific specialists. Key Requirements: Applies extensive knowledge of regulatory requirements, industry drivers, and practices to develop innovative and effective working methods. Anticipates potential changes and challenges the status quo to drive continuous improvement. Capable of strategically and proactively assessing workload, trends, tasks and priorities for cross-functional activity. Plans and executes multiple projects or activities, throughout the department, removing barriers and considering alternative methods and contingency plans to avoid potential issues and promote efficiency. Designs and implements solutions to address departmental and cross functional challenges, taking into consideration the broader impact. Engages, influences and collaborates with stakeholders on cross-functional projects of increased corporate importance. BS/BA degree in related discipline and a minimum of 21 years of related experience; or, MS/MA degree in related discipline and a minimum of 19 years of related experience; or, PhD degree in related discipline and a minimum of 17 years of related experience; or, Equivalent combination of education and experience. PhD degree preferred. At least seven years of experience of specific leadership and management experience including managing a team of regulatory and scientific professionals and management of multiple independent and interdependent functions or equivalent preferred. Experience and significant participation in preparation of complex documents for regulatory submissions, particularly IND, NDA/BLA/MAA. Certification (eg, AMWA, BELS) is preferred. In depth experience with electronic systems including submissions. #J-18808-Ljbffr