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Title:Director, Medical Writting
Salary:Open
Experience:8+
Location:MA - Cambridge

Description:

This position provides leadership and management to multi-site medical writing departments.

Responsibilities:

·         Refines and implements department vision and strategy with input from GCO leadership, Therapeutic areas, Regulatory and other R&D departments.

·         Provides strategic direction to MW staff, ensuring quality and timing of documents meets program, SMT, Global Clinical Operations and TA/SBU goals and objectives.

·         Directs and assists medical writers in the writing, editing and compilation for documents that are components of clinical/ regulatory approval applications for new biologics or NME applications. Documents include: Sections of clinical trial applications, Annual Reports, and BLA/NDAs, Protocols and Protocol Amendments, Model Informed Consents, Model Privacy Consents, Product Safety Profiles, Investigator Brochures, Clinical Study Reports, Clinical Development Plans, and Expert Reports and other documents as appropriate.

·         Provides mentoring and career development as needed to create high-quality, world-class department.

·         Is a senior member of the Global Clinical Operations Dept; functions as a strong technical leader and manager with excellent scientific, strategic, and customer-focused leadership.

·         Partners with the Clients in Clinical Operations and in R&D to ensure completion of high quality, timely, clinical documentation.

·         Is responsible for creating/ managing a high quality medical writing group that is capable of de novo high quality document creation. Provides skills development, career development, and performance management as required.

·         Manages writing resources, both internal and external, and ensures that critical program milestones are met. Allocates resources as appropriate, manages department budgets, etc. Ensures department resources align with future portfolio and program needs.

·         Manages department budgets and LRP process for Medical Writing. Develops long-term department strategies that align with R&D goals

·         Fosters a culture of customer focus and continual process improvement. Manages process re-design(s) that ensure fast-pace program milestones are met and high-quality accurate scientific documentation is produced.

·         Maintains cutting edge knowledge base of current developments in field and related technologies. Incorporates process improvements and changes that align with R&D and Global Clinical Operations needs. Develops training programs and processes that ensure medical writing staff learn and develop therapeutic and disease-specific knowledge.

·         Is a senior leader of the Global Clinical Operations Dept. Manages multiple locations, contributes to overall Global Clinical Operations strategies and initiatives.

Requirements:

·         PhD in biology or related discipline. Equivalent combination of education and experience considered.

·         10+ years of related experience in biotech or pharmaceutical environment.

·         Must have strong scientific and operational background.

·         At least 8 years of experience managing staff.

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