Director, Medical Writing

Proclinical is recruiting for a Director of Medical Writing with a leading pharmaceutical company located remotely. The primary purpose of this position is to set the strategy for authoring of clinical study related documents and regulatory submissions and to serve as the primary author of clinical study documents (study protocols, CSRs, etc).

Job Responsibilities:

• Responsible for establishing strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regard to document quality, and developing medical writing timelines, processes, and working
• Working with Clinical development and Clinical Operation team, developing the clinical study synopsis and authoring clinical protocols, amendments, and CSRs.
• Working with Clinical, Regulatory or CMC Lead, determines document authoring resource needs, proactively identifies issues and solutions, and sets timelines and
• Can independently serve as the lead writer for regulatory submission documents such as eCTD module 2, 3, and 4 summaries, meeting briefing documents, and other documents as needed.
• Writes clinical study and regulatory documents in compliance with company standard operating procedures (SOPs) and applicable health authority guidance and regulations.
• Ensures key messages are clear and consistent within and across
• Contributes strategically and scientifically at the project team
• Contributes to formation of key messages in consultation with functional area
• Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents.
• Manages vendors and external writers with regard to document quality; provides guidance to external writers on company standards and style and industry best practices for regulatory
• Develops clinical and regulatory writing timelines, processes, and working standards; ensures company SOPs, templates, style guides, etc, are aligned with industry best
• Contributes interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as
• Provide management support for activities with outside vendors and business partners, as
• Working with Clinical and Regulatory Lead, prepares Clinical Development Strategy for clinical development projects.
• Depending on experience and need, may be assigned other clinical, regulatory or operational projects within the Clinical

Skills and Requirements:

• Bachelor's Degree with a major in an analytical, data-oriented field of study from an accredited college or university is required; advanced degree is preferred.
• Minimum 8 years of relevant experience in Clinical Development, Clinical Writing, Medical Writing or a related function with pharmaceutical or biological products.
• Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable.
• Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with clinical, regulatory, medical and scientific terminology is necessar
• Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment.
• Proficiency using Microsoft Word, Excel and PowerPoint.
• Excellent oral and written English communication skills.
• Ability to present scientific and technical information in a concise and clear manner.
• Experience with ex-US regulatory submissions is a plus.

If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-388-1650 or g.watson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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