VP, Medical Writing (Regulatory)

Klein Hersh International; Alameda (CA); On-site; USD 150,000 - 250,000; Full time

Job summary

A leading company in drug discovery and development seeks a Vice President of Regulatory Science Communications. The successful candidate will manage regulatory documentation processes, ensuring timely submissions and compliance with industry standards while leading a diverse team. Ideal for a seasoned professional with a strong background in regulatory leadership and document management in pharmaceuticals.

Qualifications

• Minimum 17 years experience with a PhD, at least 19 years with MS/MA, or 21 years with BS/BA.
• Seven years of leadership experience including team management in regulatory and scientific fields.
• Experience preparing IND, NDA/BLA/MAA documents.

Responsibilities

• Leads preparation and submission of regulatory documents ensuring quality and timelines.
• Builds and manages effective teams for regulatory document development.
• Oversees budgeting and strategically manages departmental resources.

Skills

Regulatory Requirements

Project Management

Leadership

Cross-Functional Collaboration

Education

PhD in related discipline

MS/MA in related discipline

BS/BA in related discipline

Tools

Electronic Submission Systems

Job description

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.